Global Regulatory Leader, MedTech & Implants

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

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.