Manager, RA France

The Manager, RA France is responsible for leading regulatory affairs activities for the French market, ensuring compliance with local regulatory requirements and enabling timely, sustainable market access for DePuy Synthes products. This role plays a key part in supporting product lifecycle activities, managing regulatory risk, and partnering with local, regional, and global stakeholders to support business continuity and growth in a highly regulated environment.

Key Responsibilities

• Lead and manage regulatory affairs activities to support product registrations, renewals, and lifecycle management for France.

• Ensure compliance with French and applicable EU regulatory requirements, internal policies, and quality system standards.

• Serve as the primary regulatory point of contact for the France local market.

• Coordinate regulatory submissions, variations, renewals, and responses to health authority inquiries.

• Partner with cross‑functional teams including Quality, Supply Chain, Commercial, and Global Regulatory Affairs to support business objectives.

• Monitor regulatory changes and assess potential impacts to products, portfolios, and operations.

• Support regulatory audits, inspections, and compliance assessments as required.

• Contribute to continuous improvement initiatives to enhance regulatory efficiency, consistency, and compliance.

• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.

Qualifications

Education:

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required).

• Advanced degree or professional certification in Regulatory Affairs (preferred).

Experience and Skills:

Required:

• Typically 6-8 years of progressive experience in Regulatory Affairs within the medical device, healthcare, or other regulated industries.

• Strong knowledge of French and EU regulatory requirements, including EU MDR.

• Experience managing product registrations and lifecycle activities.

• Ability to interpret regulatory requirements and apply them to business and product decisions.

• Strong stakeholder management, communication, and collaboration skills.

• Ability to manage multiple priorities in a complex, fast‑paced environment.

Preferred:

• Experience supporting multi‑country regulatory portfolios.

• Experience working in a multinational or matrixed organization.

• Exposure to regulatory audits, inspections, or health authority interactions (e.g., ANSM).

• Familiarity with EU MDR implementation and post‑market requirements.

• Demonstrated experience driving regulatory or process improvement initiatives.

Other:

• Language: French and English required.

• Travel: Limited; occasional national or regional travel.

• Certifications: RAC or equivalent preferred but not required.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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