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
Salary description
£45000.00 - £55000.00 per year