Manager, Regulatory Affairs

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

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

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. Its more than making contact lenses – it 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.

Key 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.

About You

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 Experience & Education

• 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.

Key Skills

• Proofreading, Adobe Acrobat, FDA Regulations, Manufacturing & Controls, Biotechnology, Clinical Trials, Research & Development, GLP, cGMP, Product Development, Chemistry, Writing Skills.

Benefits

• Competitive compensation and bonus.
• Private medical insurance.
• 25 days holiday.
• Pension scheme.
• Healthcare cover and life assurance.
• Access to our Wellness Platform to support your mental health and wellbeing.
• Discounted contact lens scheme.
• Extensive training and career development.
• LinkedIn Learning access.
• Employee referral scheme (100 voucher reward).

What You Can Expect

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 Women 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.

Equal Opportunity Statement

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

How to Apply

Apply today! For more information, view all opportunities on our careers page.

Employment Type

Full‑Time

Functional Area

Regulatory Affairs

Experience Required

8–10 years