Regulatory Affairs Specialist
Company: Euro London Agency
- Location: Utrecht, Netherlands
- Seniority: Mid level
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Regulatory Affairs Specialist – Medical Devices | EU MDR
Do you have hands-on experience maintaining EU MDR technical documentation? Would you like to focus on product lifecycle compliance within an established Regulatory Affairs team?
We are recruiting for an international medical device company in the Utrecht area. This role suits a Regulatory Affairs professional with around 3 years’ relevant experience who enjoys working with technical files and assessing the regulatory impact of changes.
What you’ll do
- Maintain and update EU MDR technical documentation for existing medical devices.
- Assess product, process and documentation changes, identifying the regulatory actions and updates required.
- Work closely with Quality, R&D and Operations to keep technical files accurate, complete and compliant.
What you’ll bring
- Regulatory Affairs experience within the medical device industry.
- Direct experience maintaining EU MDR technical files, covering more than clinical documentation or country registrations alone.
- Practical experience assessing the regulatory impact of changes.
- Fluent English. Dutch is welcome but not required.
- Existing authorisation to work in the Netherlands and availability to work on site in the Utrecht area.
What’s on offer
- €50,000–€65,000 gross annually, including 8% holiday allowance
- Company bonus.
- Defined benefit pension plan.
- 30 days’ annual leave.
- Up to 2 days working from home per week after onboarding.
Interested?
Apply through the application link or email your English CV to t.perriaux@eurolondon.com briefly outlining your experience maintaining EU MDR technical files and assessing changes.
Please use the application link or email so your CV can be reviewed through the recruitment process.
