Principal Regulatory Affairs Specialist

CooperCompanies; Fareham; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading global contact lens manufacturer in England is seeking a highly experienced Principal Regulatory Affairs Specialist. This role involves leading regulatory strategy, ensuring compliance, and managing submissions across EMEA. Candidates should have 6-8 years of regulatory experience in the medical device sector and a scientific degree. This position offers competitive compensation, a hybrid work model, and a robust benefits package.

Benefits

Competitive salary

Private medical insurance

25 days holiday

Pension scheme

Healthcare cover

Qualifications

• 6-8 years of medical device regulatory experience.
• Understanding of ISO 13485 and EU medical device regulations.
• Ability to read and understand technical material.

Responsibilities

• Lead and approve regulatory submissions for product registrations.
• Maintain up-to-date knowledge of regional regulatory requirements.
• Support audits and regulatory inspections across various regions.

Skills

Regulatory submissions

Technical writing

Relationship building

Education

Bachelor's degree in scientific or technical discipline

Tools

Electronic document management systems

Job description

Job Description

Job title: Principal Regulatory Affairs Specialist

Department: Regulatory Affairs

Location: Delta Park, Fareham (moving to Adanac Park, Southampton in May 2026) / Hybrid or Gyal, Hungary / Hybrid

GLS: P04

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.

At CooperVision, we're big on belonging. Everyone's contribution counts, and that's why inclusion and diversity are so important. It isn't just the right thing to do; it's what makes our company the best it can be. We are committed to creating an inclusive and engaging workplace. Our Employee Resource Groups offer employees to grow within a safe and inclusive space. So be yourself, whoever you are, and let's achieve amazing things together.

Job summary - What to expect:

We're seeking a highly experienced Principal Regulatory Affairs Specialist to lead regulatory strategy and ensure compliance and shaping[ market access and regulatory strategy across EMEA.

In this pivotal role, you'll drive global and regional regulatory processes, shape procedures for marketed products, and maintain our regulatory excellence to PROTECT the business; GROW the business. If you're passionate about navigating complex regulations and making a global impact, we'd love to hear from you.

Essential Functions & Accountabilities:

• Lead and approve regulatory submissions for product registrations across assigned regions, ensuring timely and accurate documentation management.
• Maintain up-to-date knowledge of regional regulatory requirements and communicate changes and impacts to internal stakeholders.
• [NK2] Represent Regulatory Affairs in cross-functional initiatives, providing expert input on labelling, product documentation, and compliance.
• Support audits and regulatory inspections across UK, EU, ACE, and MENA regions.
• Mentor junior team members and contribute to departmental initiatives and continuous improvement efforts.
• Act as a regulatory resource for quality issues, risk mitigation, and public policy representation.
• Independently manage multiple projects and daily tasks, ensuring alignment with business and compliance objectives.
• Travel requirements (local and international) - approximately 20%

A full job description is available upon request.

About you:

We are looking for someone who has proven experience in building relationships across a diverse business, and the capability to interact effectively and credibly at senior levels. Experience in electronical document management systems is required as well as the ability to read and understand technical material.

Experience & Education:

• Bachelor's degree in a scientific or technical discipline and working knowledge of medical device regulations.
• 6-8 years of medical device regulatory experience.
• Understanding of ISO 13485 requirements and EU medical device regulations.
• Medical device industry experience including strong working knowledge and experience with MDD and MDR.
• Technical writing experience. Has experience evaluating manufacturing changes for impact on global regulatory affairs submissions.
• Experienced at reviewing and approving product labelling.
• Ability to operate in a business-driven model providing quick, salient analysis and concrete action plans emphasis on understanding and anticipating business needs and interests and devising proactive approaches/responses.

What we offer:

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

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, 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.

Please view 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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About Us

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.