Regulatory Affairs Officer F - M H/F - Astek

Founded in France in 1988, Astek is a global player in engineering and technology consulting, present on five continents. With its expertise in many industrial and tertiary sectors, it supports its international clients in the intelligent deployment of their products and services, and in the implementation of their digital transformation.Since its creation, the Group has based its development on a strong culture of entrepreneurship and innovation, and on the support and skills development of its 10 000 employees who are committed every day to promoting combination of digital technologies and complex systems engineering.Join a Group rapidly developing in France and around the world, with a turnover of 705 M€ in 2024.More on the Group on our website https://astek.net.

Joining Astek means choosing:an experience accelerator, where every assignment is an opportunity to progressaccess to a multitude of technically exciting projects for our clients as well as internallyindividualized, local support for a tailored career pathcontinuous learning, thanks to our internal training academya friendly and inclusive work environment, supported by #TopEmployer2025 certified HR practicesLet's move forward.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.