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

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.