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Open nowPosted 36 days ago

Regulatory Affairs Specialist

EURES job mobility portal42,762 open roles

Where
Utrecht, Netherlands
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Your applicationOpen nowRegulatory Affairs SpecialistEURES job mobility portal · Utrecht, Netherlands

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Share of postings closed within
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  2. 3.4%3 days
  3. 7.9%7 days
  4. 14.2%14 days
  5. 34.1%30 days
This job: posted 36 days ago

The posting

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

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