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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