15 Ofertas de Certified Compliance & Ethics Professional en Costa Rica

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.

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:

Adverse Event Report, Audits Compliance, Business Processes, Communication, Compliance Assessments, Critical Thinking, Cross-Functional Teamwork, Detail-Oriented, Process Improvement Projects, Regulatory Affairs Compliance, 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

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

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.

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

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

The Regulatory Affairs Specialist II is responsible for supporting the development and implementation of the overall objectives and regulatory strategies that impacts the introduction of new products and market status of existing products.

The Regulatory Affairs Specialist II will assist Regulatory Affairs management by supporting activities and processes as required to assure that 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 (P2) level

What will you be doing?

• Prepares international dossiers for EU and other key market affiliates, to obtain and maintain global regulatory approvals of products.
• Generates regulatory strategies for new and modified products, product support on change notifications and quality plans for US and international impact assessments.
• Provides regulatory support to global regional regulatory teams on international regulatory requirements to support registrations based on new and modified product changes.
• Provide customer service necessary regulatory / registration information for compliance and customer requests.
• Support manufacturing changes for compliance with applicable regulations, including US, EU and global international via regulatory strategy, assessments, and submission support as needed.
• Works with cross functional teams – with senior support - to deliver supporting documentation (IFU, DHF, CER etc.) during dossier creation and during review and approval of labelling and instruction for use based on changes to modified products assessed or notified body inputs.
• Ordering and legalization of documentation supporting global RA approvals such as Certificates of Free Sale.
• Update company databases with required information and statuses for licenses, registrations, renewals, products, and other required data, i.e., GUDID, DI, EUDAMED, RIMSYS, and Management of SAP for legal blocks and registrations.
• Update and maintain knowledge of current developments and changes to applicable laws, regulations, and industry standards.
• Support development of company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
• Provide support for internal and Regulatory Agency audits.
• 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 o ther duties as assigned.

What will you need to be successful?

• Bachelor's degree in Engineering, Biomedical Science, Pharmacy, Medicine, or a related field
• Experience: 2+ year(s) Regulatory Affairs medical device industry experience.
• Fluent in English (conversation, written and comprehension; Intermediate)

Competencies:

• Read, Understand, and apply global regulations.
• Technical knowledge of medical products
• Understanding of relevant procedures, practices, and associated medical terminology.
• Knowledge of product development process and design control
• 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.
• Prior experience with Product Lifecycle Management Systems and large-scale document management systems a plus
• Proficiency with SAP, Microsoft Office, Adobe, internet
• Occasional use of Personal Protective Equipment (PPE) required.
• Travel Requirements: 5-15% (Domestic and/or International)

You. Unlimited

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

Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, 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.

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

Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager

The Senior Regulatory Affairs Manager ensures all products meet regulatory standards by coordinating submissions, managing compliance, and providing strategic guidance to development teams. This role also monitors regulatory changes, oversees documentation, and manages cross-functional collaboration and talent within the team.

Your role:

• Align regulatory strategies with business goals to integrate requirements into product development and improve productivity.
• Communicate clearly with teams and regulatory agencies, ensuring transparency and a proactive approach in regulatory activities.
• Drive continuous improvement through strategic partnerships and implement automation to boost efficiency.
• Evaluate the organization's Regulatory Excellence maturity to identify areas for enhancement and guide strategic initiatives.
• Develop and update regulatory policies to ensure compliance across all business units and assess new guidelines for necessary adjustments.

You're the right fit if:

• You've acquired 8+ years of experience with Bachelor's or 6+ years of experience with Master's in areas such as Regulatory Affairs, Quality Compliance, Product Development in the Medical Devices Industry or equivalent. You are an experienced people leader in the medical devices regulatory affairs space with extensive experience with international submissions (LATAM, Japan, China, South Korea, etc.).
• You have a bachelor's Degree/master's degree in biomedical engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent. RAPS RAC preferred.
• Advanced English Level

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.

This is an office-based role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business .
• Discover our rich and exciting history.
• Learn more about our purpose.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here .

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

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