Director, Regulatory Affairs - NPI

Job title: Director, Regulatory Affairs - NPI
Department: Regulatory Affairs
Location: Southampton, UK
Working Hours: Mon – Fri, 37.5 hours per week

CooperVision is a global leader in soft contact lenses with a presence in over 100 countries. We aim to improve the way people see each day by helping lens wearers gain freedom and confidence to move about their daily lives. We’re committed to bright futures for our people and those who wear our lenses.

The Director, New Product Introduction (NPI) Regulatory Affairs leads the team responsible for developing and executing regulatory strategies that enable the successful introduction of new and revised products to CooperVision’s global markets. The role sits on the Research & Development (R&D) Senior Leadership Team and provides strategic input to ensure regulatory requirements are embedded within design and development activities. Works closely with R&D Quality Assurance to address regulatory expectations within the R&D Quality Management System (QMS) and collaborates with Regulatory Affairs, R&D, Lifecycle Management (LCM), QA, and other functions critical to product development and commercialization. The role balances strategic leadership, technical expertise, and cross-functional influence to position regulatory affairs as a strategic partner in innovation and compliance across the product lifecycle.

The role leads against the RA Mission Statement: PROTECT the Business; GROW the Business. We deliver pragmatic regulatory strategies to:

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• PROTECT the business and our freedom to operate
  
• GROW the business and create real advantages for customers and wearers
  

Provides strategic leadership in defining and executing regulatory strategies for all new and revised products developed for CooperVision’s global markets. Ensures regulatory pathways are optimized to support timely product approvals and market access. As a member of the R&D Senior Leadership Team, embeds regulatory requirements into design and development activities, ensuring they are understood and applied across R&D and LCM. Fosters cross-functional alignment to enable innovation while maintaining regulatory compliance. Leads and develops the NPI Regulatory Affairs team to deliver against strategic goals and operational objectives.

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• Leads the development and execution of pragmatic and innovative regulatory strategies to support timely market introduction of new or revised products, including oversight of clinical investigation applications.
  
• Ensures proactive integration of regulatory requirements into design and development programs, influencing early-stage decision-making to support compliance and market success.
  
• Provides strategic regulatory leadership to the R&D Senior Leadership Team, aligning with business goals.
  
• Partners with R&D Quality Assurance to embed regulatory requirements into the R&D Quality Management System.
  
• Collaborates cross-functionally to ensure technical documentation meets regulatory expectations, leveraging eQMS and RIM systems for efficient delivery.
  
• Builds, leads, and develops a high-performing NPI Regulatory Affairs team aligned with divisional strategy and the LRSP.
  
• Balances strategic, tactical, and operational responsibilities, positioning the team as subject matter experts and trusted business partners.
  
• Champions regulatory training and capability building to foster understanding and readiness for evolving requirements.
  
• Drives continuous improvement in regulatory processes, systems, and ways of working.
  
• Engages with external regulatory bodies, including notified bodies and MDSAP auditing organizations, to represent the company and influence outcomes.
  
• Ensures optimal team resourcing, structure, and skills for current and future business needs.
  
• Manages team budgets ensuring financial stewardship and alignment with annual planning.
  

Approximately 20% to global CooperVision locations.

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• Demonstrated leadership skills: able to lead through influence.
  
• In-depth knowledge of EU and US FDA medical devices regulations.
  
• Working knowledge of international medical devices regulations.
  
• Experience in Quality Management Systems, ISO13485 and MDSAP.
  
• Proven track record in managing regulatory activities relating to design and development.
  
• Ability to manage risk and achieve results.
  
• Comfortable planning under ambiguity; culturally astute for a global organization.
  
• Ability to interpret highly technical material and regulations.
  
• Ability to work under pressure and meet deadlines.
  
• Strong analytical, evaluation, and critical thinking skills.
  
• Excellent verbal and written communication and interpersonal skills.
  
• Fluent English, both spoken and written.
  
• Strong people and project management skills with the ability to prioritize multiple projects.
  
• Ability to balance big-picture thinking with technical detail and business context.
  
• Proficiency in Microsoft Office (Excel, Word, PowerPoint); advanced skills preferred.
  

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• Normal office environment.
  
• Sedentary to light physical effort; extended periods of sitting and computer use.
  

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• Strong knowledge of international regulatory environments and product registration processes; experience with optical/medical devices preferred.
  
• Strong computer, problem-solving, analytical, and communication skills.
  
• Minimum 15 years’ experience in medical devices regulatory affairs and quality assurance preferred.
  
• Minimum 8 years’ experience in a leadership role across multiple countries, languages, and cultures required.
  
• Bachelor’s degree (BA/BSc); MA/MSc or higher preferred.
  
• ISO13485 certified auditor and/or QA Manager experience a plus.
  
• Experience in the optical industry, specifically contact lenses, is a plus.
  

You’ll receive competitive compensation and a comprehensive benefits package including car allowance, bonus, private medical insurance, 25 days holiday, pension, access to Wellness Platform, a discounted contact lens scheme, and more. We support personal and professional development with extensive training and access to LinkedIn Learning to help you grow with CooperVision.

As a CooperVision employee, you’ll be welcomed into a diverse, inclusive, and progressive global organization. We value different perspectives and the role they play in our success. If you like what you see, apply today. All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.

Please view our careers page for other opportunities.