Manager, RA

Jobtailor; Issy-les-Moulineaux; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Jobtailor is seeking a Regulatory Affairs leader for France to drive registrations, lifecycle management, and compliance across the region. You will coordinate submissions, interact with health authorities, and collaborate with Quality, Supply Chain, and Commercial teams to align regulatory strategy with business goals.

The role requires French and English proficiency, 6–8 years in regulatory affairs within regulated industries, and experience with EU MDR.

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.
• 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 (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).

Responsabilités

• 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.

Formation

Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline

Description du poste

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).