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:

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

Sound interesting? Apply to find out more.