Manager, Regulatory Affairs
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Job Location:
Southampton - UK
Monthly Salary:
Not Disclosed
Posted on:
25 days ago
Vacancies:
1 Vacancy
Department:
Job Summary
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 worlds leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improvethe way people see each day. Its more than makingcontact lenses its about giving lens wearers freedom andconfidence to move about their daily lives. Were 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. Youll 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.
You will:
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.
About you:
We are looking for someone who is a confident leader highly organised and detail-oriented. Youll 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.
Experience & Education:
Required:
Bachelors degree in a scientific or technical discipline.
810 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.
What we offer:
Youll 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 well 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
What you can expect:
As a CooperVision employee youll 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 Womans 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.
Please view our careers page at view all other opportunities.
#INDHP #LI-HYBRID #LI-LD2
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Live Brightly. Our daily and monthly soft contact lenses are designed with your health and comfort in mind. For every eye, every person, and every day.
