17 Ofertas de Certified Compliance & Ethics Professional en Costa Rica

Regulatory Affairs Specialist

La Sabana ₡900000 - ₡1200000 Y Roche

Hoy

Trabajo visto

Toque nuevamente para cerrar

Descripción Del Trabajo

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

We advance science so that we all have more time with the people we love.
La Oportunidad
Garantizar el registro sanitario y actualizaciones de los productos Roche de manera pronta y oportuna ante las Autoridades Reguladoras de los diferentes países de Centroamérica, Caribe y Venezuela y trabajo conjunto con otras áreas de la organización con el fin de que la innovación llegue lo más rápidamente a los pacientes.

Responsabilidades

  • Participar en asociaciones de la industria sobre política y regulaciones, considerando la convergencia regulatoria
  • Mantener actualizadas las bases de datos y sistemas de Roche para asegurar el cumplimiento regulatorio del producto
  • Apoyar y ejecutar estrategias y planes de registro innovadores y basados en riesgo para productos asignados, acelerando el acceso a nuevas moléculas y cambios post-registro
  • Coordinar y dar seguimiento a documentaciones, muestras y estándares de referencia para nuevas moléculas y renovaciones en Centroamérica, Caribe y Venezuela
  • Asegurar que las actividades regulatorias cumplan con los estándares globales de Roche y mantener sistemas y herramientas actualizados
  • Velar por el cumplimiento de servicios brindados por registradores, distribuidores, agentes externos, etc
  • Garantizar que los trámites regulatorios estén alineados con las necesidades organizacionales para asegurar la continuidad del negocio

Quién Eres

  • Licenciatura en farmacia (PharmD), obligatoria
  • Incorporado al Colegio de Farmacéuticos de Costa Rica (COLFAR), obligatorio
  • Experiencia en el área de Asuntos Regulatorios de al menos 6 meses
  • Experiencia en las actividades regulatorias y de etiquetado en los países de Centroamérica, Caribe y Venezuela de al menos 6 meses
  • Experiencia en la interacción y participación con las partes involucradas (incluyendo las Autoridades Sanitarias y las asociaciones de la industria) de al menos 6 meses
  • Conocimiento de las regulaciones sanitarias de los países de Centroamérica, Caribe y Venezuela, incluyendo etiquetado
  • Habilidades de lenguaje: Nivel de español e inglés oral y escrito avanzado
  • Comprensión de las Buenas Prácticas de Fabricación, Almacenamiento, Distribución y Transporte para los productos farmacéuticos

Beneficios de reubicación no disponibles para este puesto de trabajo.
Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.

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Manager, Regulatory Affairs

San José, San José ₡900000 - ₡1200000 Y MSD Animal Health Ireland

Hoy

Trabajo visto

Toque nuevamente para cerrar

Descripción Del Trabajo

Job Description
We invite you to join our Team

Global Submissions Publishing, comprised of Regulatory Content Management and Submission Publishing, works closely with various stakeholders to ensure the timely completion of submission components and assemblies that adhere to global regulatory health authority policies and technical requirements as well as internal guidelines for electronic/hardcopy submissions.

This position is responsible for supporting the technical integrity of submission components, ensuring that all elements comply with essential standards necessary for submission readiness.

Key Responsibilities

  • Document Management: Set up document templates, format and publish documents, conduct quality control, and manage submission references to ensure accuracy and adherence to standards; distribute final documents as required.
  • Submission-Ready Components: Deliver submission-ready components that facilitate an efficient submission publishing assembly process.
  • Collaboration: Collaborate with authors, contributors and stakeholders to ensure high-quality outputs, enhance project outcomes and drive collective success.
  • Testing and Implementation of New Tools and Processes: Engage in the testing and evaluation of new publishing tools and processes. Provide feedback and suggestions for improvements to enhance efficiency and effectiveness.
  • Development of Administrative Documentation: Assist in the creation and maintenance of administrative documentation, including standard operating procedures, execution resources, guidelines and training materials to support publishing processes.
  • Continuous Learning and Development: Stay informed about industry trends, best practices, and regulatory changes related to publishing sciences.
  • Lead Publisher for Complex Submissions: Assume the role of lead publisher for larger, complex documents and submissions. Coordinate all publishing-related activities and delegate tasks to other publishers as needed to ensure efficient workflow.
  • Subject Matter Expertise: Serve as a subject matter expert for specific functions or processes. Evaluate activities and business processes, identifying areas in need of improvement and leading investigations into potential solutions or new ways of working.
  • Risk Management and Issue Resolution: Identify, assess, and actively resolve or escalate any risks or issues that could impact the successful completion of submissions. Collaborate with cross-functional teams to ensure timely identification and mitigation of potential challenges.
  • Management, Mentoring and Collaboration: Provide mentoring to inter-departmental and external stakeholders to enhance understanding and compliance with regulatory requirements. Manage projects and drive process improvement initiatives. Manage and develop a team of direct reports with a keen commitment to providing value. Coach staff in the concepts, methods, and nuances of regulatory project management, drug development, and regulatory operations.

Education & Experience Minimum Requirement

  • Bachelor's degree
  • Five (5) or more years of regulatory affairs experience
  • English proficiency, in oral and written

Required Experience

  • Interpersonal Skills: Ability to work collaboratively with others and communicate effectively, both verbally and in writing.
  • Technical Proficiency: Expert knowledge of computer programs such as MS Word and Adobe Acrobat Professional as well as industry standard publishing systems, with a demonstrated ability to learn new systems and technologies quickly.
  • Time Management: Strong organizational skills to manage multiple time-sensitive assignments efficiently.
  • Adaptability: Flexibility to adapt to a changing environment, staying current with new and updated processes and procedures.
  • Cultural Sensitivity: Strong interpersonal skills and experience in handling diverse cultures, with effective communication skills in English and regional languages.
  • Quality and Compliance Awareness: Demonstrates a deep understanding and executes the business value of quality and compliance, recognizing the implications and risks of non-compliance. Adjusts behaviors to drive high-quality deliverables.
  • Problem Solving and Critical Thinking: Ability to independently identify and resolve problems that arise within job responsibilities, ensuring a proactive approach to challenges.
  • Team Management and Development: Demonstrated experience in leading, managing, coaching, and developing teams.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status
Regular

Relocation:
No relocation

VISA Sponsorship
No

Travel Requirements
No Travel Required

Flexible Work Arrangements
Hybrid

Shift
1st - Day

Valid Driving License
Yes

Hazardous Material(s)
n.a

Required Skills
Business Processes, Communication, Compliance Assessments, Critical Thinking, Cross-Functional Teamwork, Detail-Oriented, Process Improvement Projects, Publishing, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Project Management, Team Management, Technical Documentation Management

Preferred Skills
Job Posting End Date:
09/10/2025

  • A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:
R

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Regulatory Affairs Intern

Roche

Ayer

Trabajo visto

Toque nuevamente para cerrar

Descripción Del Trabajo

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
**The Position**
**Regulatory Affairs Intern**
You will collaborate on various tasks within the Regulatory Affairs area, contributing to your graduation project and developing essential competencies.
**Key Responsibilities:**
+ Develop your final graduation project.
+ Collaborate on diverse tasks within the Regulatory Affairs area as assigned.
+ Ensure compliance with Roche standards.
**Requirements:**
+ Final-year Pharmacy student.
+ Basic knowledge of Regulatory Affairs in the Central America and Caribbean region.
+ Advanced oral and written Spanish and intermediate English (communication and written).
+ Understanding of Good Manufacturing, Storage, Distribution, and Transport Practices for pharmaceutical products.
+ Proficiency in Microsoft Office and PC usage.
**Competencies:**
+ High ethical and compliance standards.
+ Meticulous, analytical, and critical in daily work.
+ High degree of commitment and leadership.
+ Highly organized with the ability to prioritize tasks.
+ Excellent oral and written communication skills, including the ability to articulate clear messages from complex information/data.
+ Ability to use resources rationally to minimize waste.
**Who we are**
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
**Roche is an Equal Opportunity Employer.**
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Assoc. Spclst., Regulatory Affairs

San José, San José ₡40000 - ₡80000 Y MSD LATAM

Hoy

Trabajo visto

Toque nuevamente para cerrar

Descripción Del Trabajo

Job Description
Global Submissions Publishing, comprised of Regulatory Content Management and Submission Publishing, works closely with various stakeholders to ensure the timely completion of submission components and assemblies that adhere to global regulatory health authority policies and technical requirements as well as internal guidelines for electronic/hardcopy submissions.

Regulatory Content Management
is responsible for supporting the technical integrity of submission components, ensuring that all elements comply with essential standards necessary for submission readiness.

Key Responsibilities

  • Document Management Set up document templates, format and publish documents, conduct quality control, and manage submission references to ensure accuracy and adherence to standards; distribute final documents as required.
  • Submission-Ready Components Deliver submission-ready components that facilitate an efficient submission publishing assembly process.
  • Collaboration Collaborate with authors, contributors, and stakeholders to ensure high-quality outputs, enhance project outcomes and drive collective success.
  • Testing and Implementation of New Tools and Processes Engage in the testing and evaluation of new publishing tools and processes. Provide feedback and suggestions for improvements to enhance efficiency and effectiveness.
  • Development of Administrative Documentation Assist in the creation and maintenance of administrative documentation, including standard operating procedures, execution resources, guidelines, and training materials to support publishing processes.
  • Continuous Learning and Development Stay informed about industry trends, best practices, and regulatory changes related to publishing sciences.

Education Minimum Requirement

  • High School Diploma or equivalent (no relative experience)

Required Skills And Experience

  • Interpersonal Skills Ability to work collaboratively with others and communicate effectively, both verbally and in writing.
  • Technical Proficiency Knowledge of computer programs such as MS Word and Adobe Acrobat Professional, with a demonstrated ability to learn new systems and technologies quickly.
  • Time Management Strong organizational skills to manage multiple time-sensitive assignments efficiently.
  • Adaptability Flexibility to adapt to a changing environment, staying current with new and updated processes and procedures.
  • Cultural Sensitivity Good interpersonal skills and experience in handling diverse cultures, with effective communication skills in English and regional languages.
  • Quality and Compliance Awareness Demonstrates an understanding of the business value of quality and compliance, recognizing the implications and risks of non-compliance. Adjusts behaviors to drive high-quality deliverables.
  • Problem Solving and Critical Thinkings Ability to independently identify and resolve problems that arise within job responsibilities, ensuring a proactive approach to challenges.

Required Skills
Accountability, Accountability, Adverse Event Report, Audits Compliance, Communication, Critical Thinking, Data Quality Assurance, Delivering Value, Document Control Systems, Electronic Common Technical Document (eCTD), Employee Training Programs, Intercultural Relationships, Mentorship, Performance Improvements, Pharmaceutical Regulatory Affairs, Policy Implementation, Publishing Process, Records Retention Management, Regulatory Affairs Compliance, Regulatory Applications, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Project Management, Regulatory Strategy Development {+ 2 more}

Preferred Skills
Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status
Regular

Relocation
No relocation

VISA Sponsorship
No

Travel Requirements
No Travel Required

Flexible Work Arrangements
Hybrid

Shift
Not Indicated

Valid Driving License
No

Hazardous Material(s)
no

Job Posting End Date
10/5/2025

  • A job posting is effective until PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID
R

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Assoc. Spclst., Regulatory Affairs

San José, San José ₡30000 - ₡60000 Y MSD

Hoy

Trabajo visto

Toque nuevamente para cerrar

Descripción Del Trabajo

Job Description

Global Submissions Publishing, comprised of Regulatory Content Management and Submission Publishing, works closely with various stakeholders to ensure the timely completion of submission components and assemblies that adhere to global regulatory health authority policies and technical requirements as well as internal guidelines for electronic/hardcopy submissions.

Regulatory Content Management is responsible for supporting the technical integrity of submission components, ensuring that all elements comply with essential standards necessary for submission readiness.

Key Responsibilities:

  • Document Management: Set up document templates, format and publish documents, conduct quality control, and manage submission references to ensure accuracy and adherence to standards; distribute final documents as required.
  • Submission-Ready Components: Deliver submission-ready components that facilitate an efficient submission publishing assembly process.
  • Collaboration: Collaborate with authors, contributors, and stakeholders to ensure high-quality outputs, enhance project outcomes and drive collective success.
  • Testing and Implementation of New Tools and Processes: Engage in the testing and evaluation of new publishing tools and processes. Provide feedback and suggestions for improvements to enhance efficiency and effectiveness.
  • Development of Administrative Documentation: Assist in the creation and maintenance of administrative documentation, including standard operating procedures, execution resources, guidelines, and training materials to support publishing processes.
  • Continuous Learning and Development: Stay informed about industry trends, best practices, and regulatory changes related to publishing sciences.

Education Minimum Requirement:

  • High School Diploma or equivalent (no relative experience)

Required Skills and Experience:

  • Interpersonal Skills: Ability to work collaboratively with others and communicate effectively, both verbally and in writing.
  • Technical Proficiency: Knowledge of computer programs such as MS Word and Adobe Acrobat Professional, with a demonstrated ability to learn new systems and technologies quickly.
  • Time Management: Strong organizational skills to manage multiple time-sensitive assignments efficiently.
  • Adaptability: Flexibility to adapt to a changing environment, staying current with new and updated processes and procedures.
  • Cultural Sensitivity: Good interpersonal skills and experience in handling diverse cultures, with effective communication skills in English and regional languages.
  • Quality and Compliance Awareness: Demonstrates an understanding of the business value of quality and compliance, recognizing the implications and risks of non-compliance. Adjusts behaviors to drive high-quality deliverables.
  • Problem Solving and Critical Thinkings: Ability to independently identify and resolve problems that arise within job responsibilities, ensuring a proactive approach to challenges.

Required Skills:

Accountability, Accountability, Adverse Event Report, Audits Compliance, Communication, Critical Thinking, Data Quality Assurance, Delivering Value, Document Control Systems, Electronic Common Technical Document (eCTD), Employee Training Programs, Intercultural Relationships, Mentorship, Performance Improvements, Pharmaceutical Regulatory Affairs, Policy Implementation, Publishing Process, Records Retention Management, Regulatory Affairs Compliance, Regulatory Applications, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Project Management, Regulatory Strategy Development {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

10/5/2025

  • A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R

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Sr Regulatory Affairs Specialist

₡80000 - ₡120000 Y Smith+Nephew

Hoy

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Descripción Del Trabajo

Life Unlimited.
At Smith+Nephew we design and manufacture technology that takes the limits off living.

The Senior Regulatory Affairs Specialist developments and supports the implementation of global regulatory strategies, coordinates registrations to sustain marketing of existing products.

This role enables commercial launch of new products, supports processes, and manages data to assure that all products manufactured and /or distributed by Smith & Nephew Inc. are in full compliance with U.S. and all applicable global regulatory requirements.

This position is a P3 level
What will you be doing?

  • Prepare NPD regulatory submissions such as 510(k), technical documentation files, design dossiers for new and modified devices.
  • Acts as regulatory representative on cross functional project teams; Work closely with project teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company's product launch timelines for new and modified products.
  • Plans and Prepares international dossiers for New Product Development Key strategic markets to obtain and maintain global regulatory approvals of products to meet company product launch times.
  • Reviews and approves product, supplier and manufacturing changes for compliance with applicable regulations and applicable procedures.
  • Reviews and approves device labeling and advertising and promotional materials to ensure continued compliance to global regulations; may lead the development of regulatory strategies for new claims, indications and therapies.
  • Ensures distribution of products within SAP comply with regulatory requirements and liaise with Regulatory PLD specialist to provide updates to licensing and management of SAP license blocks, release requests for registration.
  • Updates and maintains company databases with required information and status for Unique Device Identifier, GUDID, Di, EUDAMED, RIMSYS, licenses, registrations, renewals, products, and other required data to assure compliance with business and Regulatory requirements.
  • Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements.
  • Development of departmental and corporate Standard Operating Procedures and departmental procedures, when necessary. Provides support for internal and Regulatory Agency audits.
  • Provides technical guidance to junior regulatory professionals inclusive of coaching and mentoring and guidance to cross functional teams.
  • Build Quality into all aspects of job performance by maintaining compliance to all quality requirements and participates in training and development activities as required and other duties as assigned.

What will you need to be successful?

  • Education: Bachelor's degree (BS) or higher degree in Clinical, Medical, or Scientific/Technical Disciplines.
  • Certifications: RAC Professional certification(s) (preferred).
  • Experience: 5+ years' experience in global regulatory submissions in a regulated environment (medical device).
  • 3+ years' Prior experience with Product Development and Design Control Processes and Product Lifecycle Management Systems is preferred.
  • Prior experience with Product Lifecycle Management Systems and large-scale document management systems a plus.
  • Languages: Advanced English skills.
  • Knowledge: Proficiency with SAP, Windchill, Agile, RIMSY, Microsoft Office, Adobe, internet is preferred.
  • Read, Understand, and apply global regulations.
  • Technical knowledge of medical products.
  • Knowledge of product development process and design control.
  • Competences: Understanding of relevant procedures, practices, and associated medical terminology.
  • Excellent research and analytical skills; detail oriented
  • Ability to manage multiple projects.
  • Ability to work and problem solve both independently and within a team.
  • Ability to work within deadlines as imposed by government regulations and internal guidelines.
  • Excellent written and oral communication.
  • Demonstrated strategic thinking with the tactical and operational experience to deliver objectives/results.
  • Ability to communicate effectively and work within international multidisciplinary team.

You. Unlimited
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion+Belonging-
Committed to Welcoming, Celebrating and Thriving. Learn more about Employee Inclusion Groups on our website.

Other reasons why you will love it here

  • Your future: stock purchase program, referral bonus, subsidy in transport and food, recognition program.
  • Work/Life Balance: Extra days off, birthday off, voluntary hours.
  • Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave.
  • Flexibility: Hybrid work model (for more professional roles), flexible schedules.
  • Training: Training program, unlimited learning.
  • Extra perks: employees association, and more…

We're more than just a company - we're a community Follow us on LinkedIn to see how we support and empower our employees and patients every day.

Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into
You. Unlimited.
, life, culture, and benefits at S+N.

Explore our website and learn more about our mission, our team, and the opportunities we offer.

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Regulatory Affairs Specialist II

Escazu, San José ₡60000 - ₡80000 Y Boston Scientific

Hoy

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Descripción Del Trabajo

Additional Locations: N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

Position Responsibilities:

  • Coordinate, compile, and submit regulatory filings for new and modified products to Costa Rica and Central America Health Authorities.
  • Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings;
  • Monitor and assess regulatory updates for compliance with applicable regulations and impact to regulatory filings, communicate relevant changes to internal stakeholders.
  • Collaborate cross-functionally with global and regional RA counterparts, legal representatives, commercial, marketing, and operations teams to ensure aligned execution of regulatory priorities and approvals.
  • Maintain current and accurate information in regulatory systems regarding status, approvals, and product licenses.
  • Develops and maintains positive relationships with regulatory agencies and industry associations through verbal and written communications.
  • Coordinates localization process to guarantee Costa Rica and Central America labeling requirements are met.
  • Provide regulatory input on promotional, labeling, and advertising materials in line with Central America regulations.
  • Serve as the RA point of contact for consultants and distributors to ensure accurate and compliant submissions.

Required Qualifications:

  • 3-5 years of experience as a Regulatory Affairs Specialist in medical devices in Costa Rica and Central America countries.
  • Knowledge of Central American regulations.
  • Bachelor's degree in Life Sciences (Pharmacy, Biochemistry, Biomedical Engineering or associated areas);
  • Advanced English;
  • Attention to detail and ability to identify trends, gaps etc.
  • Problem-solving skills;
  • Ability to communicate complex ideas clearly and simply both verbally and in writing;
  • Ability to effectively manage multiple projects and priorities;
  • Team player with excellent interpersonal skills.

Preferred Qualifications:

  • General knowledge of global or LATAM regulations is an asset.
  • Experience with interactions with regulators: Regulatory Intelligence and Advocacy.

Requisition ID:

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

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Regulatory Affairs Manager, Global Registrations

₡80000 - ₡120000 Y Establishment Labs

Hoy

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Descripción Del Trabajo

  • About Us:

Establishment Labs is changing the medical device, breast health, aesthetics and reconstruction industry by designing, developing, and manufacturing an innovative portfolio of advanced medical aesthetic device technologies and wellness solutions. It is currently the world's fastest-growing women's health company.

Our Femtech solutions are proudly produced at two MDSAP-certified, carbon neutral, LEED Gold certified, state-of-the-art manufacturing facilities in Costa Rica and are approved for sale in more than 85 countries.

Since 2018 the company trades on the NASDAQ stock exchange under the ticker symbol ESTA and has a market cap of around $1.8 billion.

This is an exciting opportunity to join an innovative international company in hyper-growth as we launch a significant revolution to transform the women´s aesthetics industry.

Objective
This is one of the roles of Regulatory Affairs Manager which specifically supervises and coordinates the required regulatory activities to support the business market growth strategies through product approvals and/or registrations in accordance with commercial needs and opportunities.

This role will have access to confidential and sensitive information that must be handled accordingly, therefore trustful and ethic behaviors are expected to execute this position; good interpersonal and communication skills are required since this role will have close interaction with internal departments and may be considered a Subject Matter Expert (SME).

Main Responsibilities

  • Leads the corporate regulatory registration and registration renewals process.
  • Leads the Regulatory registration team to balance workload distribution among the team members and support career development.
  • Oversee the preparation and submission of registration documentation necessary to obtain market approvals for products in all regions.
  • Maintain and control product regulatory status worldwide via the Product Safety Net.
  • Oversee the activities required for regulatory compliance at the different regulatory data bases (FDA GUDID, EUDAMED, GDSN Center, etc.)
  • Reviews, creates, and edits technical files and regulatory documents for medical devices.
  • Participates in area improvements as part of the Quality Management System.
  • Support regulatory inspections.
  • Support the Regulations Gap Assessment process.
  • Supports the QMS Change Control review process from the regulatory perspective.
  • Leads responses to regulatory entities regarding questions that may come up from the regulatory review and submissions.
  • Reports out on status of regulatory processes or regulatory requirements.
  • May fulfilled the Regulatory Affairs role in certain QMS processes and documents.

Job Requirements

  • University Degree in applied science or other related area or equivalent experience.
  • Knowledge of ISO, FDA, CE Mark, Risk Management and other quality standards and regulations applicable to medical devices.
  • Computer literacy is required, knowledge of commercial software package (i.e. Windows or similar) and basic computer configuration
  • Advanced English
  • Proficiency in other languages is a plus (French, Portuguese, others).
  • Experience in a regulated industry.
  • Experience working in the Regulatory Affairs areas.
  • Highly developed soft skills and the ability to communicate effectively both verbally and in writing, with diverse audiences.
  • 5-10 years' experience in a regulated industry (e.g., medical devices, pharmaceutical).
  • 2 or more years of experience working in the Regulatory Affairs areas.
  • 2 years in personnel supervisor role, at least 1 year as a manager.

Important Note: This job description includes the necessary aspects required to evaluate this job position. It should not be used as a comprehensive list of all responsibilities, skills or functions.
At Establishment Labs we're committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability (visible and not visible), gender, gender identity or expression, or veteran status. We strive to be a more equal opportunity workplace.

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Legal and Compliance Operational Specialist

San Francisco ₡60000 - ₡120000 Y Moody's

Hoy

Trabajo visto

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Descripción Del Trabajo

At Moody's, we unite the brightest minds to turn today's risks into tomorrow's opportunities. We do this by striving to create an inclusive environment where everyone feels welcome to be who they are—with the freedom to exchange ideas, think innovatively, and listen to each other and customers in meaningful ways. Moody's is transforming how the world sees risk. As a global leader in ratings and integrated risk assessment, we're advancing AI to move from insight to action—enabling intelligence that not only understands complexity but responds to it. We decode risk to unlock opportunity, helping our clients navigate uncertainty with clarity, speed, and confidence.

If you are excited about this opportunity but do not meet every single requirement, please apply You still may be a great fit for this role or other open roles. We are seeking candidates who model our values: invest in every relationship, lead with curiosity, champion diverse perspectives, turn inputs into actions, and uphold trust through integrity.

Skills and Competencies

  • Strong verbal and written communication skills, with the ability to clearly convey complex information and draft documents needing minimal editing.
  • Proficient in Microsoft Office Suite applications, including Outlook, Word, Excel, PowerPoint, and SharePoint, with knowledge of collaborative tools.
  • Demonstrated proficiency in artificial intelligence concepts, with hands-on experience using AI tools to streamline workflows and enhance operational efficiency. Proven ability to implement AI-powered solutions to solve business challenges. Demonstrates a growing awareness of AI risk management and a commitment to responsible and ethical AI use. Experience with Microsoft Copilot Studio Advance is preferred.
  • Detail-oriented and organized with strong time management, multitasking, and adaptability to shifting priorities.
  • Ability to identify alternative solutions, anticipate requirements, and take proactive steps to address them.
  • Skilled in handling sensitive and confidential data and information.
  • Demonstrated expertise in managing board processes and procedures with administrative proficiency.
  • Previous experience in financial services or professional services environments preferred.

Education

  • Professional certifications, project management, operations or finance are an asset.

Responsibilities

  • Support legal and compliance operations through tech, process optimization, vendor management, and cross-functional collaboration
  • Provide departmental support to optimize legal and compliance operations that help achieve business goals.
  • Coordinate strategic legal and compliance initiatives with internal and external stakeholders.
  • Evaluate, and assist with the implementation, and management of legal technology solutions to improve operational efficiency.
  • Serve as a point of contact for legal tech vendors, managing licensing, renewals, and support escalations.
  • Analyze workflows, identify inefficiencies, and recommend process improvements.
  • Create dashboards and reporting frameworks to track Objectives and Key Results (OKRs), including key performance indicators (KPIs) and supporting the preparation of materials for meetings and presentations.
  • Assist with budgeting and tracking expenses in alignment with financial goals.
  • Support vendor relationship management including law firms, consultants, and technology providers.

About the team

Our Legal and Compliance Operations team is responsible for optimizing legal and compliance processes and supporting Moody's business goals. We contribute by ensuring robust corporate governance, supporting key strategic initiatives, and facilitating effective board operations. By joining our team, you will be part of exciting work in corporate governance, strategic operations, and global compliance, with a focus on adopting AI-driven solutions to enhance efficiency and innovation.

Moody's is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender expression, gender identity or any other characteristic protected by law.

Candidates for Moody's Corporation may be asked to disclose securities holdings pursuant to Moody's Policy for Securities Trading and the requirements of the position. Employment is contingent upon compliance with the Policy, including remediation of positions in those holdings as necessary.

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Legal and Compliance Operational Specialist

San Francisco ₡60000 - ₡120000 Y myGwork - LGBTQ+ Business Community

Hoy

Trabajo visto

Toque nuevamente para cerrar

Descripción Del Trabajo

This job is with Moody's, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
At Moody's, we unite the brightest minds to turn today's risks into tomorrow's opportunities. We do this by striving to create an inclusive environment where everyone feels welcome to be who they are—with the freedom to exchange ideas, think innovatively, and listen to each other and customers in meaningful ways. Moody's is transforming how the world sees risk. As a global leader in ratings and integrated risk assessment, we're advancing AI to move from insight to action—enabling intelligence that not only understands complexity but responds to it. We decode risk to unlock opportunity, helping our clients navigate uncertainty with clarity, speed, and confidence.

If you are excited about this opportunity but do not meet every single requirement, please apply You still may be a great fit for this role or other open roles. We are seeking candidates who model our values: invest in every relationship, lead with curiosity, champion diverse perspectives, turn inputs into actions, and uphold trust through integrity.

Skills And Competencies

  • Strong verbal and written communication skills, with the ability to clearly convey complex information and draft documents needing minimal editing.
  • Proficient in Microsoft Office Suite applications, including Outlook, Word, Excel, PowerPoint, and SharePoint, with knowledge of collaborative tools.
  • Demonstrated proficiency in artificial intelligence concepts, with hands-on experience using AI tools to streamline workflows and enhance operational efficiency. Proven ability to implement AI-powered solutions to solve business challenges. Demonstrates a growing awareness of AI risk management and a commitment to responsible and ethical AI use. Experience with Microsoft Copilot Studio Advance is preferred.
  • Detail-oriented and organized with strong time management, multitasking, and adaptability to shifting priorities.
  • Ability to identify alternative solutions, anticipate requirements, and take proactive steps to address them.
  • Skilled in handling sensitive and confidential data and information.
  • Demonstrated expertise in managing board processes and procedures with administrative proficiency.
  • Previous experience in financial services or professional services environments preferred.

Education

  • Professional certifications, project management, operations or finance are an asset.

Responsibilities

  • Support legal and compliance operations through tech, process optimization, vendor management, and cross-functional collaboration
  • Provide departmental support to optimize legal and compliance operations that help achieve business goals.
  • Coordinate strategic legal and compliance initiatives with internal and external stakeholders.
  • Evaluate, and assist with the implementation, and management of legal technology solutions to improve operational efficiency.
  • Serve as a point of contact for legal tech vendors, managing licensing, renewals, and support escalations.
  • Analyze workflows, identify inefficiencies, and recommend process improvements.
  • Create dashboards and reporting frameworks to track Objectives and Key Results (OKRs), including key performance indicators (KPIs) and supporting the preparation of materials for meetings and presentations.
  • Assist with budgeting and tracking expenses in alignment with financial goals.
  • Support vendor relationship management including law firms, consultants, and technology providers.

About The Team
Our Legal and Compliance Operations team is responsible for optimizing legal and compliance processes and supporting Moody's business goals. We contribute by ensuring robust corporate governance, supporting key strategic initiatives, and facilitating effective board operations. By joining our team, you will be part of exciting work in corporate governance, strategic operations, and global compliance, with a focus on adopting AI-driven solutions to enhance efficiency and innovation.

Moody's is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender expression, gender identity or any other characteristic protected by law.

Candidates for Moody's Corporation may be asked to disclose securities holdings pursuant to Moody's Policy for Securities Trading and the requirements of the position. Employment is contingent upon compliance with the Policy, including remediation of positions in those holdings as necessary.

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