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Regulatory Affairs Associate

2 months ago

Oxfordshire, United Kingdom Cure Talent Full time

Cure Talent is thrilled to partner with a leading Medical Devices Manufacturer, who due to continued growth, has an exciting opportunity for an experienced Regulatory Affairs Associate to join their team.

As the new Regulatory Affairs Associate, you will be responsible for supporting global product registrations, maintaining design dossiers, and ensuring compliance with international regulatory requirements. This is a dynamic role where you'll 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.

Skills & Qualifications:

  • 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