Manager, RA

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.

Requirements

• 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).
• Language: French and English required.
• Limited; occasional national or regional travel (Other).