Regulatory Affairs Specialist
Netherlands (Hybrid – minimum 2 days onsite)
We’re partnering with a high-growth MedTech company that is expanding its Regulatory Affairs team. This role sits at the intersection of field actions, vigilance, and post-market surveillance, supporting compliance across EU and local legislation.
You’ll play a key role in ensuring regulatory processes run smoothly while working closely with commercial, quality, and operational teams. This is a great opportunity for someone who enjoys combining regulatory expertise with cross-functional collaboration in a dynamic environment.
Key Responsibilities
- Support the preparation, execution, and follow-up of Field Safety Corrective Actions (FSCAs)
- Manage follow-up on Competent Authority inquiries related to field actions and vigilance
- Support PMS activities, including complaint handling guidance
- Provide regulatory support for tenders, customer requests, and internal stakeholders
- Source and verify regulatory documentation for external and internal use
- Ensure accurate updates in regulatory reporting systems and maintain proper record-keeping
Your Profile
- 3–5 years’ experience in medical device regulatory, quality, or product-related roles, or a relevant degree in Regulatory Affairs, Pharmacy, Engineering, or another scientific discipline
- Experience supporting FSCAs, vigilance, or PMS activities
- Familiarity with EU medical device regulatory requirements
- Proficient in Microsoft Office (advanced Excel skills preferred)
- Strong written and verbal communication skills in English and Dutch (French and/or German is a plus)
- Organised, detail-oriented, and comfortable working independently while collaborating across teams