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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