Chargement en cours

Manager, RA France

ISSY LES MOULINEAUX
il y a 1 jour

DePuy Synthes is recruiting for a Manager, RA France located in Issy-Les-Moulineaux, 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.

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

Qualifications

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

Required Experience and Skills

  • 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

  • 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 Requirements

  • Language: French and English required.
  • Travel: Limited; occasional national or regional travel.
  • Certifications: RAC or equivalent preferred but not required.

Benefits

  • Annual bonus with set target (% of pay) depending on pay grade / location.
  • Vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave.
  • Well‑being reimbursement, programs for financial, physical and mental health.
  • Service anniversary and recognition awards.
  • Eligibility for various insurance plans based on location and plan terms.

Salary

€60,400.00 – €103,960.00

EEO Statement

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.

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Entreprise
Johnson & Johnson MedTech
Plateforme de publication
WHATJOBS
Offres pouvant vous intéresser
FRANCE
il y a 20 jours
ISSY LES MOULINEAUX
il y a 2 jours
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