Cure Talent are delighted to be partnered with a growing medical device manufacturer with a broad and diverse product portfolio across areas including IV therapy, diabetes care, surgical, anaesthesia and consumer health. Following continued expansion, they are now looking to add another Regulatory Affairs Specialist to their Quality & Regulatory team.
As the new Regulatory Affairs Specialist, you will support the ongoing development, maintenance and execution of regulatory activities across the business. This is a hands-on role with exposure across the full product lifecycle, working closely with internal teams to ensure products remain compliant across multiple global markets while helping to define regulatory strategy.
To be successful as the new Regulatory Affairs Specialist, you will have proven experience operating within Regulatory Affairs in the medical device sector, with detailed exposure to technical documentation, global regulatory frameworks including MDR and FDA, and supporting regulatory strategy across a range of products.
Key Responsibilities
Support and maintain the Quality Management System in line with ISO 13485 requirements
Prepare, review and maintain technical documentation across MDD, MDR, IVDR, UKCA, FDA and procedure packs
Ensure ongoing compliance with applicable regulatory requirements and standards
Support document control activities including procedures, labelling and product documentation
Contribute to UDI implementation and product lifecycle activities
Coordinate and support internal and external audits
Monitor regulatory changes and support implementation across the business
Experience and Skills Required
Proven Regulatory Affairs experience within the medical device industry
Experience supporting regulatory strategy and submissions activities
Working knowledge of MDR and FDA regulatory frameworks
Strong understanding of ISO 13485
Experience working with technical documentation and regulatory files
Strong organisational skills with attention to detail
Ability to work cross-functionally within a regulated environment
If you have the necessary skills and experience, please get in touch with Kris Holmes today or click apply now
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