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Regulatory affairs specialist

Didcot
Permanent
Cure Talent Ltd
Regulatory affairs specialist
Posted: 19h ago
Offer description

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 ...

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