Regulatory Affairs Specialist

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