Cure Talent are delighted to be partnered with a medical device manufacturer as they look to strengthen their Regulatory Affairs capability. We have an exciting opportunity for a Regulatory Affairs Specialist to join an established regulatory team and support international market access activities for complex medical devices.
As the new Regulatory Affairs Specialist, you will support worldwide product registrations and lifecycle maintenance, working closely with the Regulatory Affairs Manager to ensure products meet international regulatory requirements. This is a hands-on role with strong exposure to technical documentation, Class III devices, and cross-functional collaboration with Sales, Marketing, and technical teams.
Key Responsibilities
* Support worldwide product registration submissions and ongoing maintenance activities.
* Assist with new product registrations across international markets.
* Maintain Design Dossiers and Technical Files in line with regulatory requirements.
* Support complaint file reviews and regulatory programmes for new and existing products.
* Work closely with Sales and Marketing to ensure labelling, advertising, and promotional materials comply with applicable regulations.
* Support the regulatory function to ensure timely and compliant delivery of products to market.
* Prepare Rest of World submissions following internal review and approval.
Experience and Skills Required
* Experience working in a Regulatory Affairs support role within a medical device company.
* Knowledge and experience working with Class III medical devices.
* Strong understanding of regulatory frameworks applicable to Class III devices.
* Experience writing and maintaining technical documentation.
* Calm, confident communicator able to work effectively with technical stakeholders.
* Knowledge or experience working to ISO 13485 is desirable.
If you’re a Regulatory Affairs professional looking to build further experience across international registrations and Class III devices within a collaborative medical device environment, we’d love to hear from you.