Director, Regulatory Affairs - NPI

CooperCompanies; Eastleigh; On-site; GBP 80,000 - 120,000; Full time

Job summary

A leading medical device manufacturer is seeking a Director of Regulatory Affairs - NPI to lead regulatory strategies for new and revised products. The role involves providing strategic input, ensuring compliance, and overseeing the Regulatory Affairs team to facilitate product launch in global markets. Candidates should have extensive experience in regulatory affairs, particularly within medical devices, strong leadership capabilities, and a commitment to fostering an inclusive workplace culture. This position is based in Eastleigh, UK.

Benefits

Competitive compensation

Car allowance

Bonus

Private medical insurance

25 days holiday

Pension scheme

Access to Wellness Platform

LinkedIn Learning access

Qualifications

• Minimum 15 years' experience in medical devices regulatory affairs.
• Minimum 8 years in a leadership role across multiple countries.
• Strong knowledge of international business and regulatory environments.

Responsibilities

• Lead the development and execution of regulatory strategies.
• Ensure integration of regulatory requirements into design and development.
• Provide strategic insight to the R&D Senior Leadership Team.

Skills

Leadership skills

Knowledge of EU and US FDA regulations

Analytical evaluation and critical thinking

Excellent communication skills

Project management skills

Fluent English

Education

Bachelor's degree (BA/BSc)

MA/MSc or higher degree

Tools

Microsoft Office

Quality Management Systems

Job description

Job Description

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

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.

Scope:
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. Operating as a key member of the Research & Development (R&D) Senior Leadership Team, the role provides strategic input and ensures regulatory requirements are embedded within design and development activities. The position partners closely with R&D Quality Assurance to ensure regulatory expectations are effectively addressed within the R&D Quality Management System (QMS). It also works in close collaboration with the broader Regulatory Affairs function, R&D, Lifecycle Management (LCM), and QA, while maintaining strong engagement with other functions critical to product development and commercialization. This role requires a balance of strategic leadership, technical expertise, and cross-functional influence, helping to ensure that regulatory affairs is positioned as a strategic partner in driving innovation and compliance across the product lifecycle. The position leads against the RA Mission Statement: PROTECT the Business; GROW the Business: We will engage as trusted and strategic business partners, delivering pragmatic solutions and creative regulatory strategies to: PROTECT the business and our freedom to operate; GROW the business and create real advantages for customers and wearers.

Job Summary:
The Director, NPI Regulatory Affairs provides strategic leadership in defining and executing regulatory strategies for all new and revised products developed for CooperVision’s global markets. This role ensures that regulatory pathways are optimized to support timely product approvals and market access. As a member of the R&D Senior Leadership Team, the Director plays a critical role in embedding regulatory requirements into design and development activities, ensuring they are clearly understood and consistently applied across both R&D and Lifecycle Management (LCM) functions. The role fosters cross-functional alignment, enabling innovation while maintaining compliance with evolving global regulatory standards. The Director leads and develops the NPI Regulatory Affairs team, ensuring team members are equipped with the skills, resources, and direction needed to deliver against strategic goals and operational objectives. Through effective leadership, coaching, and performance management, the role cultivates a high-performing, engaged, and future-ready team.

Essential Functions & Accountabilities:

• Leads the development and execution of pragmatic and innovative regulatory strategies to support the 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 and insight to the R&D Senior Leadership Team, shaping direction and priorities in alignment with business goals.
• Partners with R&D Quality Assurance to embed regulatory requirements into the R&D Quality Management System, ensuring robust and compliant processes.
• Collaborates cross-functionally to ensure technical documentation meets internal and external regulatory expectations, leveraging electronic Quality Management System (eQMS) and Regulatory Information Management (RIM) systems for efficient delivery.
• Builds, leads, and develops a high-performing NPI Regulatory Affairs team, aligning objectives with divisional strategy and the Long-Range Strategic Plan (LRSP).
• Balances strategic, tactical, and operational responsibilities, positioning the team as both subject matter experts and trusted business partners.
• Champions regulatory training and capability building across stakeholder groups to foster understanding, compliance, and readiness for evolving requirements.
• Drives continuous improvement in regulatory affairs processes, systems, and ways of working to enhance efficiency, quality, and agility.
• Engages with external regulatory bodies, including notified bodies and Medical Device Single Audit Programme (MDSAP) auditing organizations, to represent the company and influence regulatory outcomes.
• Ensures optimal team resourcing and capability, aligning structure and skills with current and future business needs.
• Manages team budgets effectively, ensuring financial stewardship and alignment with annual planning expectations.

Travel Requirements
Approximately 20% to global CooperVision locations.

Knowledge, Skills and Abilities

• Demonstrated leadership skills: a proven leader who can lead others 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.
• A proven track record in the management of regulatory activities relating to design and development.
• Ability to achieve results while managing risks.
• Comfortable planning under conditions of ambiguity.
• Culturally astute and able to flex style accordingly to meet the needs of a global organisation.
• Ability to read and understand highly technical material and interpret regulations.
• Ability to work under pressure and adhere to deadlines.
• High analytical evaluation and critical thinking skills.
• Excellent communication (both verbal and written) and interpersonal skills.
• Fluent command of spoken and written English.
• Excellent people and project management skills, with ability to prioritise and handle several projects concurrently.
• Valued for the ability to look at the big picture, to understand technical details, as well as to have a good sense for business.
• Computer proficiency in Microsoft Office required, including intermediate skills in the use of Excel, Word and PowerPoint. Advanced skills preferred.
• Normal office environment.
• Sedentary to light physical effort necessary to perform the job.
• There will be extended periods of sitting and using a computer.

Experience and Education

• Strong knowledge of international business, regulatory environments, regulations and legal product registration processes is required, as well as proficient product knowledge acquired through experience.
• Strong computer skills, problem solving ability, 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 working across multiple countries, languages and cultures required.
• Bachelor’s degree (BA/BSc) from four-year college or university.
• MA/MSc or higher degree preferred.
• ISO13485 certified auditor and/or QA Manager experience a plus.
• Experience working in the optical industry, specifically contact lenses, is a plus.

What we offer:
You’ll receive competitive compensation and a fantastic benefits package including car allowance, bonus, private medical insurance,25 days holiday, pension scheme, 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 your 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 an inclusive culture is and how different perspectives add value and contribute to our success.

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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Locations 36 School Lane, Eastleigh, Hampshire, SO53 4LY, GB (On-site)