Head of QARA

Are you looking for an exciting new career challenge?

We're looking for an experienced QARA professional to step into a pivotal role leading regulatory and quality activities at an innovative MedTech scale-up based just outside Paris (30 mins from the city, next to a major train line).

The role:

You'll be joining a company that's grown from 7 to over 30 people, developing a first-in-class neurovascular device, enabling real-time stroke treatment outcomes. The organisation has run three successful clinical trials, with regulatory filings underway in the US and Japan, including a Breakthrough Device Designation from the FDA.

What we're looking for:

1. 5+ years in QARA (Class III device experience strongly preferred)
2. Strong grasp of ISO-based QMS, CAPA, change control, and audit processes
3. Regulatory strategy experience across EU, US (FDA), and Japan (PMDA)
4. Comfortable bridging engineers, clinical teams, and regulators
5. Able to travel for audits outside the EU if needed
6. Professional English and French required

Sound interesting? Apply to find out more.