| Ideal start date | Asap, January (can ramp up into Feb 1st) |
| Language | English and Dutch (preferred) |
| Location | Amsterdam (Hybrid) |
| Working hours | 32-40 |
| Period | 6 months |
The Head of Compliance is responsible for all compliance teams, including RA/QA, Information Security and Privacy.
Must-haves
- Experience in Medical Device companies: ISO13485 and MDD/MDR
- Leadership & management skills to lead team of 4 fte including experienced compliance team members
- Willing to both lead the team and fill the gaps with operational work
Should-haves (ideals)
- Experience with Information security ISO27001/NEN7510 and/or Privacy GDPR
- Enough technical understanding of software development to work with compliance in SaMD company
Nice-to-haves
- Experience with recruitment to help fill HoC role
Responsibilities:
- A mix of management (2 people), and hands-on QA/RA support.
- Specifics: Company has a privacy lawyer who needs a manager to oversee them; and there is an ongoing IT project that needs to be coordinated.
- Company has 3 upcoming audits (x2 QMS, X1 MDR), so you will support them in this. MDR audit is being managed by senior RA Consultant, so you will just act as overarching support here.
- More hands-on work required for QA side (comments from audit/ CAPAs; advise on QMS gaps etc)
Process: Interview with CTO, then RA specialist via teams or on-site.