Regulatory Affairs Lead, Medical Devices (France/EMEA)

Thornton Tomasetti; Rungis; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Abbott in France (Rungis) seeks a Regulatory Affairs Senior Specialist to lead regulatory activities across the EMEAP region, focusing on France. You will drive regulatory strategy, ensure compliance with global and local requirements, and support lifecycle management of diabetes care products in a matrixed international environment.

Responsibilities include preparing technical documentation for CE marking, in-country submissions, and advising cross‑functional teams on MDR/IVDR compliance.

Qualifications

• Min. Bachelor’s degree in a scientific discipline.
• Strong MDR (EU 2017/745) knowledge including CE marking for medical devices; IVDs a plus.
• 5+ years in regulatory affairs, with France experience.
• Lead regulatory strategy for launches, changes, labeling updates.
• Excellent English and French communication; cross-functional collaboration.

Responsabilités

• Lead regulatory activities for new product launches and rollouts across EMEAP.
• Prepare, review, and maintain high‑quality technical documentation including CE files.
• Support in‑country regulatory submissions, registrations, reimbursements, and tenders.
• Provide regulatory guidance for marketing materials and promotions.
• Monitor and communicate regulatory intelligence for assigned countries.
• Advise on MDR/IVDR and local regulatory requirements; support updates.
• Coordinate strategy for design or labeling changes with authority interactions.
• Participate in internal and external audits with regulatory impact.
• Ensure compliance with Abbott’s Quality System, ISO 13485, MDR/IVDR, local regs.

Connaissances

Regulatory strategy

MDR/IVDR

France regulatory

Cross-functional

English/French

Formation

Bachelor's degree

Description du poste

Abbott in France (Rungis) seeks a Regulatory Affairs Senior Specialist to lead regulatory activities across the EMEAP region, focusing on France. You will drive regulatory strategy, ensure compliance with global and local requirements, and support lifecycle management of diabetes care products in a matrixed international environment.

Responsibilities include preparing technical documentation for CE marking, in-country submissions, and advising cross‑functional teams on MDR/IVDR compliance.