Our Client, an international leader in the medical devices sector, is looking for a Senior Regulatory Affairs Specialist to join their ranks.
As the first person in the Regulatory Department in Warsaw, you would join a small global team coordinating and monitoring regulatory submissions across all regions.
Your tasks will include:
- coordinating regulatory submissions across several regions (EU and non-EU)
- tracking and monitoring submissions across all countries
- advising local RA and manufacturers on regulatory changes, interpretations, issues
- supporting local RA in complex cases
- maintaining technical files and regulatory documentation for products (hardware and software)
- at least 5 years of experience in regulatory affairs
- experience with medical devices regulatory submissions (ideally global rather than only EU)
- fluent English (C1)
- good communication and project management skills
Warsaw
