Manager, Regulatory Affairs

Job title: Regulatory Affairs Manager

Department: Regulatory Affairs

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

GLS: M03

Working hours: 37.5 Hours Weekly

A brighter future awaits you

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.

Job summary - What to expect:

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.

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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.
  

A full job description is available upon request.

We are looking for someone who is a confident leader, highly organised, 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.

Required:

• 
  
• 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.
  

Preferred:

• 
  
• 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. To help us achieve our goals, we\'ll give you everything you need to help you achieve yours.

We also provide access to LinkedIn Learning to help you develop in you career and grow with CooperVision

As a CooperVision employee, you\'ll be welcomed into a diverse and progressive global business. We appreciate how important fostering a diverse and inclusive culture is and how different perspectives add value and contribute to our success. With our CooperPride, African Descent, Woman\'s Impact Network and Mind Body and Wellbeing Employee Resource Groups, we offer opportunities for employees to learn and grow within an inclusive and safe space.

If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.

We operate a candidate referral scheme, so if you know anyone who could be a perfect fit for this role, please email their CV to referafriend@coopervision quoting the job reference code to enjoy a £100 voucher reward if they are successful!

Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1to view all other opportunities.

#INDHP #LI-HYBRID #LI-LD2

CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.

At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and an employee-centric culture fuel a deeply engaged, high performing organization.

CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That\'s a strong reflection of our corporate culture-and part of the reason CooperVision may be a great workplace for you.