Regulatory Specialist

Regulatory Specialist (Fixed-Term Contract)

We are supporting a medical device company in the search for a Regulatory Specialist to support regulatory activities across the full product lifecycle. This role works closely with Clinical, Quality, R&D, and Operations teams to support regulatory submissions and ongoing compliance.

This is a fixed-term contract role (February-October 2026), offering exposure to both EU MDR and FDA regulatory activities within a collaborative, cross-functional environment.

Key Responsibilities

• Support the preparation and maintenance of EU MDR technical documentation
• Maintain regulatory submission documentation for global authorities
• Manage packaging and labelling regulatory requirements
• Maintain applicable standards lists and document traceability
• Support regulatory monitoring and impact assessments
• Contribute to audit and inspection readiness activities

Key Criteria

• 1–3 years of experience in medical device regulatory affairs
• Experience with Active Implantable Medical Devices is a plus
• Hands-on exposure to EU MDR technical documentation and FDA submissions
• Working knowledge of ISO 13485 and ISO 14971
• Fluency in English (French is a plus)

If this sounds like something you’d like to explore, feel free to reach out directly for a confidential conversation.

? f.signorello@panda-int.com

? +31 (0)20 20 44 502