RAQA Project Manager M/F

By joining our team, you will be the guarantor of the compliance and continuous improvement of our processes. Your main missions will be as follows:

International Regulatory Affairs:

• Prepare registration files related to export activities
• Ensure compliance of relationships with distributors in connection with the MDR regulation
• Manage communication with export clients, both internal and external

Materiovigilance:

• Act as a substitute for the materiovigilance correspondent
• Draft reporting decisions
• Ensure feedback is provided to clients

Normative Watch:

• Participate in monitoring the CE marking file framework
• Conduct documentary, normative, and bibliographic research

Notified Body:

• Follow up on and assemble responses to questions asked by the Notified Body during the technical file evaluation
• Track invoices
• Contribute to the MDR transition

We are looking for a professional with solid experience in regulatory affairs in the medical device field.

You possess excellent knowledge of regulation (EU) 2017/745 (MDR) as well as the ISO 13485 standard, and are comfortable with international normative and regulatory requirements.

Your ability to analyze processes, conduct audits, and propose continuous improvement actions is a true asset.

Possessing a rigorous mindset, you demonstrate clarity in your communications, know how to work collaboratively with multidisciplinary teams, and place customer satisfaction at the heart of your priorities.

Proficiency in English, both written and spoken, is indispensable for evolving in an international environment.