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Regulatory Affairs Specialist

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 a key role in their Regulatory Affairs team.

Job Summary

We are seeking an experienced Regulatory Affairs 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.
  • Facilitate new product registrations and ensure timely delivery.
  • Maintain Design Dossiers and Technical Files, ensuring accuracy and completeness.
  • Support regulatory activities related to change note approvals and complaint file reviews.
  • Collaborate with cross-functional teams to deliver new and existing products in compliance with global regulatory standards.

Requirements:

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

About the Role

This is a dynamic role that requires a strong understanding of global regulatory frameworks and the ability to work collaboratively with cross-functional teams.

What We Offer

Cure Talent is committed to providing our clients with exceptional talent and expertise. We are excited to partner with a leading Medical Devices Manufacturer to fill this key role and support their continued growth and success.