Spécialiste Affaires Règlementaires

Talents Solutions; Besançon; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A medical device company in Bourgogne-Franche-Comté seeks a Regulatory Affairs Specialist to ensure compliance with EU regulations throughout the product lifecycle. The role requires a degree in Life Sciences and 2-5 years of experience in regulatory affairs for medical devices. Candidates must have solid knowledge of EU MDR 2017/745 and be fluent in English and French. This is an opportunity to work in a dynamic MedTech environment with a collaborative culture and real impact on innovative products.

Qualifications

• 2–5 years of experience in Regulatory Affairs for medical devices.
• Solid knowledge of EU MDR 2017/745.
• Familiarity with ISO 13485 and ISO 14971.

Responsabilités

• Prepare, review, and maintain EU MDR technical documentation.
• Ensure compliance with Regulation (EU) 2017/745.
• Participate in CE marking activities and regulatory submissions.
• Collaborate closely with Quality, R&D, Clinical and Industrial teams.

Connaissances

Fluent English

Knowledge of EU MDR 2017/745

Cross-functional collaboration

Formation

Degree in Life Sciences, Biomedical Engineering, Pharmacy or equivalent

Description du poste

REGULATORY AFFAIRS SPECIALIST – MEDICAL DEVICES

THE COMPANY

Medical device company operating in a highly regulated environment, developing and commercializing innovative products for international markets. The company is committed to quality, regulatory compliance, and patient safety.

THE OPPORTUNITY

As a Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance of medical devices throughout their lifecycle, from development to market access and post-market activities. You will work closely with Quality, R&D, and cross-functional teams in a regulated MedTech environment.

RESPONSIBILITIES

Prepare, review, and maintain EU MDR technical documentation (Annex II & III)

Ensure compliance with Regulation (EU) 2017/745 (MDR)

Participate in CE marking activities and regulatory submissions

Support change control and assess regulatory impact of product modifications

Interface with Notified Bodies and competent authorities

Contribute to post-market activities (PMS, PMCF, vigilance)

Participate in regulatory intelligence and monitoring of regulatory changes

Collaborate closely with Quality, R&D, Clinical and Industrial teams

REQUIRED PROFILE

Degree in Life Sciences, Biomedical Engineering, Pharmacy or equivalent

2–5 years of experience in Regulatory Affairs for medical devices

Solid knowledge of EU MDR 2017/745

Experience with technical documentation and CE marking

Familiarity with ISO 13485 and ISO 14971

Ability to work in a cross-functional and international environment

Fluent English (written and spoken); French required

WHY JOIN?

Join a dynamic MedTech environment with strong regulatory challenges

Hands‑on regulatory role with real impact on product lifecycle

Collaborative culture and close interaction with technical teams

Long‑term opportunity in a stable and regulated industry