Global Regulatory Lead for MedTech & Robotics

Corin Group; Bradley Stoke; Hybrid; GBP 85,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

25 days holiday

Excellent pension

Life assurance

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. This pivotal leadership role carries responsibility for regulatory strategy, compliance, market access and execution across a diverse product portfolio including orthopaedic implants, software, and robotic devices.

You will oversee a global team, act as PRRC, and drive submissions and registrations across EU/UK/US/Australia, partnering with R&D, Quality, Clinical and Operations to ensure

Qualifications

• Degree or equivalent in Life Sciences, Engineering, or related field.
• Extensive Regulatory Affairs experience in the medical device industry.
• Strong knowledge of EU MDR, UK regulations, FDA requirements and other major frameworks.
• Experience leading regulatory submissions and engaging with authorities.
• Broad understanding of regulatory requirements for orthopaedic implants, software, digital and robotic devices.
• Proven leadership of Regulatory Affairs teams with managing complex workloads.
• Excellent judgement, decision-making, and stakeholder influencing.
• Willingness to travel internationally.

Responsibilities

• Lead and develop the Global Regulatory Affairs team with clear priorities.
• Act as the organisation's PRRC.
• Develop and execute global regulatory strategies for development and market access.
• Ensure timely regulatory submissions and licence maintenance across EU, UK, US, Australia, and others.
• Provide regulatory leadership across implant/instrument and tech portfolios.
• Collaborate with R&D, Quality, Clinical, Operations and Product Management.
• Oversee regulatory impact assessments, documentation and changes.
• Build interfaces between Regulatory Affairs and wider business functions.
• Lead interactions with regulators, notified bodies, authorities; manage submissions and audits.
• Monitor evolving global requirements and implement impact.

Skills

Leadership experience

Global regulatory strategy

People management

Regulatory compliance

Education

Degree in Life Sciences or Engineering

Job description

Corin Group is seeking a Head of Regulatory Affairs to lead the Global Regulatory Affairs function. This pivotal leadership role carries responsibility for regulatory strategy, compliance, market access and execution across a diverse product portfolio including orthopaedic implants, software, and robotic devices.

You will oversee a global team, act as PRRC, and drive submissions and registrations across EU/UK/US/Australia, partnering with R&D, Quality, Clinical and Operations to ensure