Les missions 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
Le profil recherché
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.
Astek en images
Publiée le 12/05/2026 - Réf : 5001
