Senior Regulatory Affairs Specialist – Regulatory Intelligence

Job title: Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist

Department: Regulatory Affairs

Location: Delta Park Fareham (moving in Southampton in May 2026) / Hybrid

GLS: P02/P03

Working hours: 37.5 Weekly

A brighter future awaits you

CooperVision is one of the worlds leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improvethe way people see each day. Its more than makingcontact lenses its about giving lens wearers freedom andconfidence to move about their daily lives. Were all about bright futures for our people and those who wear our contact lenses.

Job summary What to expect:

As aRegulatory Affairs Specialist/Senior Specialist Regulatory Intelligence youll play a pivotal role in supporting CooperVisions Contact Lens and Contact Lens Care business. Youll collaborate across a wide range of global regional and local teams including Regulatory Affairs Quality Systems Clinical Professional Services R&D Marketing and Manufacturing. Youll also engage with external stakeholders such as Ministries of Health (e.g. the FDA) and Notified Bodies helping to ensure our products meet evolving regulatory requirements worldwide.

Regulatory Affairs Specialist

Focus: Expert-level support in gathering analysing and disseminating global regulatory intelligence.

Key Responsibilities

• Conducts scientific and regulatory information searches.
• Summarizes and assesses regulatory trends approvals and strategies.
• Supports development of regulatory strategies by providing timely intelligence.
• Collaborates with Global and Regional Regulatory Affairs teams.
• Provides both routine and ad hoc intelligence reports.

Senior Regulatory Affairs Specialist

Focus: Strategic leadership and expertise in regulatory intelligence to influence regulatory strategies and policies.

Key Responsibilities

• Ensures regulatory/competitive intelligence is provided to the business.
• Proactively monitors emerging external scientific and regulatory trends.
• Influences development of regulatory strategies and policies across portfolio areas.
• Works with Global and Regional Regulatory Affairs to provide requested information.
• Implements a commenting process on health authority guidance and directives.

A full job description for both positions is available upon request.

About you:

We are looking for someone who has excellent collaboration/relationship building skills as well as strong influencing and negotiation skills. You will also require working knowledge of US regulations and guidance including but not limited to FDA 21 CFR MDSAP ISO 13485 UKCA MedDO MDD and MDR and possess the ability to read and understand highly technical material.

Specific skills for each role are listed below:

Experience & Education:

Regulatory Affairs Specialist

• 1-3 years of Regulatory Intelligence Experience required.
• Sound knowledge of intelligence tools and methods.
• Bachelor of Science degree or equivalent preferred; Bachelor of Arts degree or equivalent accepted based on experience.
• Working knowledge of regulations and guidance governing medical device in all phases of development including post-marketing in the US and/or EU.
• Understand and interpret complex scientific issues across projects as it relates to regulatory requirements regulatory intelligence and strategy for the region.

Senior Regulatory Affairs Specialist

• 1-5 years of Regulatory Intelligence Experience required.
• Sound knowledge of intelligence tools and methods
• Bachelor of Science degree or equivalent preferred; Bachelor of Arts degree or equivalent accepted based on experience. Advanced degree preferred.
• Knowledge of regulations and guidance governing medical device in all phases of development including post-marketing in the US and/or EU with a good understanding of basic regulatory requirements in emerging markets.
• Must be strong overall and able to train/develop staff in the area of regulatory intelligence such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory trends.

What we offer:

Youll receive competitive compensation and a fantastic benefits package including; 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 well 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 youll 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.

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 view all other opportunities.

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