Job Description
Regulatory Affairs Manager
* Department: Regulatory Affairs
* Location: Delta Park, Segensworth (Moving to Nursling Southampton in May 2026) / Hybrid
* Working Hours: 37.5 Hours Weekly
Company Overview
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.
Job Summary
As the Regulatory Affairs Manager, 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.
Responsibilities
* 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.
Qualifications
* Required:
o Bachelor’s degree in a scientific or technical discipline.
o 8–10 years of medical device regulatory experience.
o Strong working knowledge of MDD and MDR.
o Experience in technical writing and evaluating manufacturing changes for regulatory impact.
* Preferred:
o Experience with electronic document management systems.
o Strong IT, analytical, and communication skills.
o Ability to work effectively in multinational/multicultural environments.
Benefits
* Competitive compensation and bonus structure.
* Private medical insurance.
* 25 days holiday.
* Pension scheme.
* Health care cover.
* Life assurance.
* Wellness Platform support.
* Discounted contact lens scheme.
EEO Statement
All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
#J-18808-Ljbffr