Senior Regulatory Affairs Lead - Medical Devices (Hybrid)

CooperCompanies; Southampton; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading global manufacturer of optical products seeks a Regulatory Affairs Manager to lead a team ensuring compliance with EU MDR and global regulatory requirements. The candidate should have 8-10 years of medical device regulatory experience and strong knowledge of MDD and MDR. This position offers competitive compensation and benefits, along with an inclusive work environment. The role is based in Southampton and involves hybrid working arrangements.

Benefits

Competitive compensation and bonus

Private medical insurance

25 days holiday

Pension scheme

Healthcare cover and life assurance

Wellness Platform access

Discounted contact lens scheme

Extensive training and career development

LinkedIn Learning access

Employee referral scheme

Qualifications

• 8–10 years of medical device regulatory experience.
• Strong working knowledge of MDD and MDR.
• Experience in technical writing and evaluating manufacturing changes for regulatory impact.

Responsibilities

• Lead and manage a team of Regulatory Affairs Specialists.
• Maintain up-to-date knowledge of regional and national regulations.
• Author and compile Technical Files for CE approval.
• Represent Regulatory Affairs in cross‑functional teams.

Skills

Proofreading

FDA Regulations

Manufacturing & Controls

Biotechnology

Clinical Trials

Research & Development

GLP

cGMP

Product Development

Chemistry

Writing Skills

Education

Bachelor’s degree in a scientific or technical discipline

Tools

Electronic document management systems

Job description

A leading global manufacturer of optical products seeks a Regulatory Affairs Manager to lead a team ensuring compliance with EU MDR and global regulatory requirements. The candidate should have 8-10 years of medical device regulatory experience and strong knowledge of MDD and MDR. This position offers competitive compensation and benefits, along with an inclusive work environment. The role is based in Southampton and involves hybrid working arrangements.