Regulatory Affairs Officer H/F Astek

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