Senior Principal Regulatory Affairs Specialist (Senior Manager)

CooperCompanies; United Kingdom; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

A global leader in vision care is seeking a Senior Principal Regulatory Affairs Specialist to influence market access and regulatory strategies across EMEA. This role requires expertise in regulatory frameworks and a strong background in managing regulatory submissions. The ideal candidate will demonstrate leadership qualities and thrive in multicultural environments. Competitive compensation and comprehensive benefits are offered.

Benefits

Car allowance

Bonus

Private medical insurance

25 days holiday

Pension scheme

Healthcare cover

Life assurance

Wellness platform

Contact lens scheme

Qualifications

• 8-12 years of experience in the regulated medical device industry.
• Extensive experience with regulatory submissions and technical documentation.
• Proven track record managing complex regulatory projects and audits.

Responsibilities

• Develop and implement regulatory strategies for projects.
• Provide expert guidance to cross-functional teams.
• Lead registration activities and maintain documentation systems.

Skills

Attention to detail

Organizational skills

Technical writing skills

Excellent communication skills

Multitasking capabilities

Education

Bachelor’s degree in a scientific or technical discipline

Advanced degree and Regulatory Affairs Certification preferred

Tools

MS Office

Relational database systems

Electronic document management systems

Job description

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Senior Principal Regulatory Affairs Specialist (Senior Manager)

Location: United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: d4bd9842386e

Job Views: 5

Posted: 12.08.2025

Expiry Date: 26.09.2025

Job Description:

Job title: Senior Principal- Regulatory Affairs Specialist (Senior Manager)

Department: Regulatory Affairs

Multiple Locations Available:

• Delta Park, Segensworth moving to Southampton in May 2025 / Hybrid
• Madrid, Spain / Hybrid
• Sophia Antipolis, France / Hybrid
• Milan, Italy / Hybrid
• Gorinchem, Netherlands / Hybrid

GLS: P5

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 about giving lens wearers freedom and confidence to move about their daily lives. We’re committed to creating an inclusive and engaging workplace where everyone can belong and grow.

Job summary – What to expect:

Join us as a Regulatory Affairs Senior Principal and influence market access and regulatory strategy across EMEA – including the EU, CIS, ACE, and MENA regions. Lead global strategy from product conception to launch, collaborating with the EMEA Commercial leadership team to deliver pragmatic solutions and creative leadership, championing the Regulatory Affairs mission: PROTECT the business; GROW the business.

Essential Functions & Accountabilities:

• Develop and implement regulatory strategies for projects
• Provide expert guidance to cross-functional teams
• Ensure a unified voice regarding requirements
• Lead registration activities and maintain documentation systems
• Monitor regulatory changes and communicate impacts
• Review and approve product labelling and marketing materials
• Support private label and own-brand customers, liaising with EU authorities
• Collaborate with global teams in packaging, supply chain, QA, and R&D
• Mentor junior team members and represent the company with regulatory bodies
• Travel approximately 20% for local and international purposes

A full job description is available upon request.

About you:

We seek a leader who can influence decision-makers and demonstrates strong leadership qualities. You should have a deep understanding of regulatory frameworks including ISO 13485, MDSAP, MDD, MDR, and other relevant standards, ensuring compliance and driving quality excellence.

To succeed, you need:

• Exceptional attention to detail, organizational, and technical writing skills
• Proficiency in MS Office and relational database systems
• Ability to thrive in multinational and multicultural environments
• Excellent communication skills and multitasking capabilities

Experience & Education:

• Bachelor’s degree in a scientific or technical discipline
• 8-12 years of experience in the regulated medical device industry
• Extensive experience with regulatory submissions and technical documentation
• Proven track record managing complex regulatory projects and audits
• Experience with electronic document management systems
• Advanced degree and Regulatory Affairs Certification preferred

What we offer:

Competitive compensation, benefits including car allowance, bonus, private medical insurance, 25 days holiday, pension scheme, healthcare cover, life assurance, wellness platform, contact lens scheme, and more. We support personal and professional growth through extensive training and access to LinkedIn Learning.

What you can expect:

Be part of a diverse, inclusive global business that values different perspectives and fosters an inclusive culture.