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Regulatory Affairs Specialist

1 month ago

Oxford, Oxfordshire, United Kingdom Cure Talent Full time
Job Opportunity

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

This dynamic position 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 excel in this role, please get in touch with the team at Cure Talent today.