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Regulatory Affairs Specialist

2 months ago

Oxford, Oxfordshire, United Kingdom Cure Talent Full time
Regulatory Affairs Associate Job Description

Cure Talent is partnering with a leading Medical Devices Manufacturer to fill an exciting opportunity for an experienced Regulatory Affairs Associate.

This role involves supporting global product registrations, maintaining design dossiers, and ensuring compliance with international regulatory requirements.

The successful candidate will collaborate with cross-functional teams to deliver new and existing products to market.

This is a hybrid role with twice weekly site visits.

We are seeking an experienced regulatory professional with proven expertise in MDR, particularly for Class III devices, and a strong understanding of global regulatory frameworks.

Key Responsibilities:

  • Coordinate worldwide product registration submissions and ongoing maintenance.
  • Facilitate new product registrations.
  • Maintain Design Dossiers and Technical Files.
  • Support regulatory activities related to change note approvals and complaint file reviews.
  • Assist in delivering new and existing products in compliance with global regulatory standards.

Requirements:

  • Proven experience in a Regulatory Affairs role in Medical Devices.
  • Knowledge and experience of Class III Medical Devices.
  • Proven experience with technical file creation, maintenance, and development.
  • Strong working knowledge and experience with ISO 13485.
  • Knowledge of Product Registrations, preferably Worldwide.

If you have the necessary skills and experience to be successful in this role, please get in touch with the team at Cure Talent today.