Chargement en cours

Manager, RA France

LYON, 69
il y a 2 jours

Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations

Issy-les-Moulineaux, France; Lyon, Rhone, France

Job Title

Manager, RA France – located in Issy-Les-Moulineaux, France.

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

  • 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 (required).
  • Strong knowledge of French and EU regulatory requirements, including EU MDR (required).
  • Experience managing product registrations and lifecycle activities (required).
  • Ability to interpret regulatory requirements and apply them to business and product decisions (required).
  • Strong stakeholder management, communication, and collaboration skills (required).
  • Ability to manage multiple priorities in a complex, fast‑paced environment (required).
  • 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).

Other

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

Required Skills

Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility

Preferred Skills

Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility

The anticipated base pay range for this position is

€60 400,00 - €103 960,00

Benefits

In addition to base pay, we offer the following benefits: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer 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. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Equal Opportunity 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.

Accessibility Statement

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 internal employees contact AskGS to be directed to your accommodation resource.

Company Information

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit

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.

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Entreprise
Johnson & Johnson
Plateforme de publication
WHATJOBS
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