IVDR Regulatory Affairs Specialist for IVDs

Astek; Lyon; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading CRO company in Lyon is seeking a Regulatory Affairs Officer to ensure compliance of IVD products with IVDR regulations. The ideal candidate will have 2-5 years of experience in regulatory affairs for medical devices and a solid understanding of EU Regulation 2017/746. You will support regulatory activities, prepare technical documentation, and ensure labeling compliance. Join a collaborative environment where you will work with QA, R&D, and Marketing teams.

Qualifications

• 2-5 years of experience in regulatory affairs for medical devices or IVDs.
• Solid understanding of IVDR and related guidance.
• Knowledge of ISO 13485 and risk management requirements.

Responsabilités

• Support regulatory activities related to CE marking under IVDR.
• Prepare and update technical documentation for IVD products.
• Ensure compliance of labeling and claims with IVDR.

Connaissances

Experience in regulatory affairs for medical devices

Understanding of EU Regulation 2017 / 746 (IVDR)

Knowledge of technical documentation

Formation

Higher education in Life Sciences or Regulatory Affairs

Description du poste

A leading CRO company in Lyon is seeking a Regulatory Affairs Officer to ensure compliance of IVD products with IVDR regulations. The ideal candidate will have 2-5 years of experience in regulatory affairs for medical devices and a solid understanding of EU Regulation 2017/746. You will support regulatory activities, prepare technical documentation, and ensure labeling compliance. Join a collaborative environment where you will work with QA, R&D, and Marketing teams.