Manager, Regulatory Affairs

CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.

As the Regulatory Affairs Manager of our Regulatory Affairs team, you will lead a team of specialists to ensure compliance with EU MDR and global regulatory requirements. You’ll play a key role in protecting and growing the business by providing expert regulatory guidance, managing technical documentation, and supporting product registrations across multiple regions.

Delta Park, Segensworth (Moving to Nursling Southampton in May 2026) / Hybrid

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• Lead and manage a team of Regulatory Affairs Specialists, fostering a high-performance culture.
  
• Maintain up-to-date knowledge of regional and national regulations and communicate changes to stakeholders.
  
• Author and compile Technical Files for CE approval and coordinate responses to Notified Body requests.
  
• Represent Regulatory Affairs in cross-functional teams and technical audits across UK, EU, ACE, and MENA regions.
  
• Review and approve product labelling and liaise with Competent Authorities and Ministries of Health.
  
• Provide input to Regulatory Affairs Impact Documents (RAIDs) and support CE marking and regional registrations.
  
• Independently manage multiple projects, department initiatives, and day-to-day tasks.
  

We are looking for someone who is a confident leader, highly organized, and detail-oriented. You’ll thrive in cross-functional environments and be comfortable navigating complex regulatory landscapes. Your ability to influence, educate, and drive projects to completion will be key to your success.

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• Bachelor’s degree in a scientific or technical discipline.
  
• 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.
  

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• Experience with electronic document management systems.
  
• Strong IT, analytical, and communication skills.
  
• Ability to work effectively in multinational/multicultural environments.
  

You’ll receive competitive compensation and a fantastic benefits package including bonus, private medical insurance, 25 days holiday, pension scheme, healthcare cover, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more! We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. We also provide access to LinkedIn Learning.

All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.

Visit our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1 to view all other opportunities.

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• Mid-Senior level
  

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• Full-time
  

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• Legal
  

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• Medical Equipment Manufacturing