Regulatory Affairs Officer

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

Alsinova, the Astek Group subsidiary offering a complete CRO solution, is recruiting a Senior Preclinical Biostatistician for a project in the pharmaceutical sector.

Your mission (should you decide to accept it) :

As a Regulatory Affairs Officer, you will contribute to ensuring that the company's IVD products remain compliant with the evolving IVDR regulations and other applicable standards.

Your daily activities will be :

• Support regulatory activities related to CE marking under IVDR
• Prepare, review, and update technical documentation (TD) for IVD products in accordance with IVDR Annex II & III
• Ensure compliance of labeling, Instructions for Use (IFU), and claims with IVDR and applicable national regulations
• Participate in gap assessments, risk management documentation, and post-market surveillance strategies
• Contribute to interactions with notified bodies or regulatory authorities as needed
• Collaborate cross-functionally with QA, R&D, Clinical, and Marketing teams

You :

• Higher education in Life Sciences, Regulatory Affairs, or related field.
• 2-5 years of experience in regulatory affairs for medical devices or IVDs.
• Solid understanding of EU Regulation 2017 / 746 (IVDR) and related guidance.
• Experience with technical documentation, CE marking, and notified body submissions.
• Knowledge of ISO 13485, risk management (ISO 14971), and post-market requirements.