Regulatory Affairs Manager

Johnson & Johnson

Manager, RA France leading regulatory affairs activities for DePuy Synthes products. Ensuring compliance with local and EU regulatory requirements for market access.

Posted 7/10/2026full-timeIssy-les-Moulineaux • 🇫🇷 FranceMid-LevelSenior💰 €60,400 - €103,960 per yearWebsite

About the role

Key responsibilities & impact

Lead regulatory affairs activities for the French market.
Ensure compliance with local regulatory requirements.
Enable timely, sustainable market access for DePuy Synthes products.
Support product lifecycle activities.
Manage regulatory risk.
Partner with local, regional, and global stakeholders.
Coordinate regulatory submissions, variations, renewals, and responses to health authority inquiries.
Monitor regulatory changes and assess potential impacts to products, portfolios, and operations.
Contribute to continuous improvement initiatives to enhance regulatory efficiency, consistency, and compliance.
Ensure proactive engagement in shaping regional policy initiatives critical to business strategy, continuity, and growth.

Requirements

What you’ll need

Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required).
Advanced degree or professional certification in Regulatory Affairs (preferred).
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.
Experience supporting multi‑country regulatory portfolios (preferred).
Experience working in a multinational or matrixed organization (preferred).
Exposure to regulatory audits, inspections, or health authority interactions (e.g., ANSM) (preferred).
Familiarity with EU MDR implementation and post‑market requirements (preferred).
Demonstrated experience driving regulatory or process improvement initiatives (preferred).
Fluency in French and English (required).

Benefits

Comp & perks

Annual bonus with a target percentage of pay depending on grade/location; actual payment is based on employee and company performance for the previous calendar year, or sales commissions.
Paid vacation/annual leave.
Parental leave for a minimum of 12 weeks.
Bereavement leave.
Caregiver leave.
Volunteer leave.
Well‑being reimbursement.
Programs for financial, physical, and mental health support.
Service anniversary and recognition awards.
Employees — and in some locations eligible dependents — can participate in various insurance plans.

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Hard Skills & Tools

Regulatory ComplianceProduct Lifecycle ManagementRegulatory SubmissionsRegulatory Risk ManagementRegulatory AuditsEU MDR ImplementationHealth Authority InteractionsRegulatory Process ImprovementRegulatory Changes MonitoringMulti-Country Regulatory Portfolios

Soft Skills

Communication SkillsCollaboration SkillsStakeholder EngagementPrioritization SkillsAdaptability

Certifications

Professional Certification In Regulatory Affairs