Regulatory Specialist

Overview

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.

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 ...