Regulatory Affairs Associate

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

As the new Regulatory Affairs Associate, you will be responsible for supporting global product registrations for both new and existing devices, maintaining technical files & design dossiers and ensuring compliance with international regulatory requirements.

To be successful as the new Regulatory Affairs Associate, we are looking for an experienced Regulatory Affairs professional who ideally has experience with Class III devices and has experience of coordinating new and/or existing product registrations.

This is a hybrid role with the expectation of being on site in Didcot twice a week.

Key Responsibilities:

• Coordinate worldwide product registrations and compliance
• Maintain and update technical files and design dossiers
• Support post-market surveillance obligations and associated reporting
• Review technical, marketing, and legal documentation for regulatory compliance
• 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.

What You Will Need:

• 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 are passionate about regulatory affairs and want to play a pivotal role in ensuring global compliance within a respected Medical Device Manufacturer, we would love to hear from you!