Field Sales Associate (f / m / d) Endovascular Aortic - Rhône Alpes Area - Home Office

W. L. Gore & Associates; Paris; À distance; EUR 60 000 - 80 000; Plein temps

Résumé du poste

An innovative medical device start-up in France is seeking a Head of Quality Assurance & Regulatory Affairs. This role is pivotal in ensuring compliance with EU regulations and FDA standards while working closely with the Senior Leadership Team. The successful candidate will oversee the Quality Management Systems and lead a team focused on post-market surveillance. This position offers the flexibility of remote work, with occasional travel to Paris or Nice, making it an exciting opportunity for professionals passionate about advancing AI in medical imaging. If you are ready to make a significant impact in a dynamic environment, this role is for you.

Qualifications

• Bachelor's degree in a Life Science field required.
• 4+ years of experience in Regulatory Affairs essential.

Responsabilités

• Develop and maintain Quality Management Systems including audits and CAPAs.
• Liaise with Notified Bodies and Certification Bodies.

Connaissances

Regulatory Affairs

Quality Management Systems

Post-market Surveillance

ISO 27001 Knowledge

Collaboration with Senior Leadership

Formation

Bachelor’s degree in Life Science

Description du poste

Apsida Life Science are currently partnered with one of the leading medical device start-ups in France who specialise in Artificial Intelligence applied to medical imaging. The team are seeking a Head of Quality Assurance & Regulatory Affairs to join the team. Although remote, this person MUST be living in France and able to travel to either Paris or Nice occasionally.

With the aim to develop a ‘digital radiologist’ and their dedication towards cancer screening, they have won large awards for their innovative approach to AI / software. You’ll be collaborating closely with the Senior Leadership Team (reporting to the CEO), being the main regulatory point of contact for EU regulations and the FDA.

Responsibilities :

1. Overall responsibility for developing, implementing and maintaining the Quality Management Systems (internal and external audits, CAPAs, assessing non-conformities, post-market data).
2. Key liaison with Notified Bodies, Certification Bodies and Competent Authorities.
3. Act as the PRRC. Ensure the post-market surveillance obligations are complied with EU MDR.
4. Close collaboration with the Senior Leadership Team.
5. Manage the Quality Engineer & QA Manager.

Requirements :

1. Bachelor’s degree in a Life Science focussed field.
2. 4+ years of experience in Regulatory Affairs.
3. Must have experience in SaMD (AI / Medical Imaging / devices with software embedded).
4. Knowledge and experience of EU medical device regulation (MDR).
5. ISO 27001 (information security) knowledge is a highly preferred.