Regulatory Affairs Specialist
On-site · Copenhagen, Capital Region, Denmark
Job Summary
Regulatory Affairs Specialist responsible for Nordic regulatory activities in Denmark, coordinating Field Safety Corrective Actions (FSCAs), responding to competent authorities, guiding sales on product complaint handling to ensure regulatory compliance, and maintaining regulatory documentation requests. Supports Nordic QMS per EN ISO 13485:2016 (supplier/distributor management, document control, KPI monitoring) and collaborates with cross-functional teams to implement regulatory updates, ensure timely inquiries responses, and support post-market surveillance while communicating in English and Danish. Requires a degree in Engineering, Life-sciences, Biology or related advanced field with at least 2 years of regulatory experience; strong analytical, organizational, and communication skills; ability to work independently in a multicultural environment. Location: Copenhagen, Denmark; full-time role with on-site presence in the Nordic region.
Required Qualifications
- Degree in Engineering, Life-sciences, Biology or other relevant advanced degree
- At least 2 years experience in Regulatory Affairs
- Fluency in English and Danish; additional Nordic languages advantageous
- Strong computer skills (Microsoft Office)
- Ability to work independently and manage multiple tasks
- Detail-oriented with focus on quality and patient safety
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