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Regulatory Affairs Associate

2 months ago


Oxford, Oxfordshire, United Kingdom Cure Talent Full time

Job Opportunity

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

Job Summary

We are seeking an experienced regulatory professional to support global product registrations, maintain design dossiers, and ensure compliance with international regulatory requirements.

Key Responsibilities

  • Coordinate worldwide product registration submissions and ongoing maintenance.
  • 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.

About the Role

This is a hybrid role with twice weekly site visits, requiring a strong understanding of global regulatory frameworks and the ability to work effectively in a team environment.

What We Offer

Cure Talent is committed to providing a supportive and challenging work environment that allows our professionals to grow and develop their careers.