Head of Regulatory Affairs

Corin Group; Cirencester; On-site; GBP 85,000 - 90,000; Full time

Benefits offered by this job

Salary £85,000–£90,000 depending on 경험

Discretionary annual bonus

Pension 6% to 9.7% after 18 months

Private medical insurance

Eye tests and flu vaccinations

Job summary

Corin Group is seeking a Head of Regulatory Affairs to lead the Global Regulatory Affairs function for a diverse portfolio including orthopaedic implants, instruments, software and robotic devices.

The role oversees regulatory strategy, submissions, and licence maintenance across key markets and requires strong leadership and cross-functional collaboration to ensure regulatory excellence throughout the product lifecycle.

Qualifications

• Experience leading Regulatory Affairs in medical devices.
• Leadership responsibility in regulatory teams.
• Knowledge of EU MDR, UK regulations, FDA requirements.
• Experience with regulatory submissions and interacting with authorities.

Responsibilities

• Lead and develop the Global Regulatory Affairs team with clear priorities.
• Act as PRRC and custodial regulatory compliance authority.
• Develop and execute global regulatory strategies for product development and registrations.
• Ensure timely regulatory submissions and licence maintenance across EU, UK, US, Australia and other markets.
• Provide regulatory leadership across implant/instrument and software, digital, robotic devices.
• Collaborate with R&D, Quality, Clinical, Operations and Product Management.
• Oversee regulatory impact assessments, documentation, manufacturing changes, and commitments.
• Interface regulatory affairs with wider business functions.
• Lead interactions with authorities, notified bodies and regulatory organisations.
• Monitor evolving regulatory requirements and assess impact.
• Provide guidance and escalate risk to senior leadership.

Skills

Regulatory leadership

Global regulatory strategy

Stakeholder communication

Cross-functional collaboration

Travel flexibility

Education

Degree in Life Sciences/Engineering

Job description

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
• 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