Job Title: Regulatory Affairs Officers – Two Positions
Location: Utrecht area | Work Type: Hybrid | Full-time | Salary: €50,000–€65,000
We are seeking two Regulatory Affairs Officers to join an international medical device company located in the Utrecht area. We are looking for candidates with complementary profiles to enhance our existing team of three professionals.
Key Responsibilities
- Product Lifecycle / EU MDR:
- Maintain and update EU MDR Technical Documentation / Technical Files.
- Assess regulatory impact of product, process, and documentation changes.
- Collaborate closely with Quality, R&D, and Operations teams.
- International Registrations:
- Manage registrations, renewals, and change notifications across international markets.
- Prepare and maintain regulatory dossiers.
- Track submissions across multiple countries.
- Coordinate with local representatives and internal stakeholders.
Your Profile
You possess hands-on Regulatory Affairs experience within the medical device industry, ideally with expertise in one of the following areas:
- Maintenance of EU MDR Technical File / Technical Documentation.
- International medical device registrations and submissions.
Fluency in English is required, while knowledge of Dutch or other languages is an advantage.
Package
- Salary: €50,000–€65,000 gross/year, including 8% holiday allowance
- 4% company bonus
- Defined Benefit pension plan
- 30 days of annual leave
- Up to 2 days working from home per week after onboarding
Interested?
Apply online using the form below. Only applications matching the job profile will be considered.
Work location, Switzerland