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Open nowPosted 37 days ago

Head of Regulatory Affairs

coringroup54 open roles

Where
Corinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK
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Your applicationOpen nowHead of Regulatory Affairscoringroup · Corinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK

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This job: posted 37 days ago

The posting

Head of Regulatory Affairs Location: Flexible / HybridTravel: Frequent international travel required Lead Global Regulatory Strategy for Innovative Medical Technologies Corin is seeking an experienced and strategic Head of Regulatory Affairs to lead our Global Regulatory Affairs function. This is a pivotal leadership role with overall accountability for regulatory strategy, compliance, market access, and regulatory execution across our diverse and innovative product portfolio. As the single point of accountability for Regulatory Affairs, you will provide direction and oversight across a broad range of medical technologies, including orthopaedic implants and instruments, as well as cutting-edge software, digital and robotic medical devices. You will play a key role in ensuring regulatory excellence throughout the product lifecycle while supporting the successful delivery of Corin's growth ambitions worldwide. What You'll Be Doing

Lead and develop the Global Regulatory Affairs team, ensuring strong performance, clear priorities and effective resource management. Act as the organisation's Person Responsible for Regulatory Compliance (PRRC). Develop and execute global regulatory strategies that support product development, product changes, registrations and continued market access. Ensure timely, high-quality regulatory submissions, registrations and licence maintenance across key global markets including the EU, UK, US, Australia and other international territories. Provide regulatory leadership across both implant/instrument and technical product portfolios, ensuring the appropriate expertise is applied to each area. Serve as the senior Regulatory Affairs representative within cross-functional teams, collaborating closely with R&D, Quality, Clinical, Operations and Product Management. Oversee regulatory impact assessments, technical documentation, manufacturing and product changes, and regulatory commitments. Build effective interfaces and accountability between Regulatory Affairs and wider business functions. Lead significant interactions with regulatory authorities, notified bodies and regulatory organisations, including submissions, responses, audits and meetings. Monitor evolving global regulatory requirements and ensure their impact is effectively assessed and implemented. Provide expert regulatory guidance and risk escalation to senior leadership. Deputise for the Global Director of QA, RA & Clinical on regulatory matters when required.

About You We're looking for a proven Regulatory Affairs leader who combines deep technical expertise with strong people leadership skills. You will have:

A degree, or equivalent qualification, in Life Sciences, Engineering or a related discipline. Extensive Regulatory Affairs experience within the medical device industry, including leadership responsibility. Strong working knowledge of global medical device regulations, including EU MDR, UK regulations, FDA requirements and other major international frameworks. Experience leading regulatory submissions and engaging directly with regulatory authorities and notified bodies. Broad understanding of regulatory requirements relating to orthopaedic implants and instruments, alongside software, digital and robotic medical devices. Demonstrated success in leading and developing Regulatory Affairs teams while managing complex workloads and competing priorities. Excellent judgement and decision-making capabilities. Strong communication and influencing skills, with the ability to translate complex regulatory matters for senior stakeholders. Flexibility to travel internationally and participate in meetings across multiple global time zones.

Why Join Corin? At Corin, we're transforming orthopaedics through pioneering technologies that help surgeons improve outcomes and enhance patients' lives. As Head of Regulatory Affairs, you'll have the opportunity to shape global regulatory strategy, influence business decisions at the highest level, and play a key role in bringing innovative medical technologies to markets around the world.

A competitive salary £85,000 - £90,000 dependant on experience and a discretionary annual bonus 25 days holiday plus bank holidays Excellent pension – starts at 6%, going up to 9.7% after 18 months. Life assurance – Six times your basic salary Private medical insurance with BUPA for you and your family Free annual eye tests and flu vaccinations

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