Job Description
Job title: Senior Regulatory Affairs Specialist - Regulatory Intelligence
Department: Regulatory Affairs
Location: Fareham, Hampshire moving to Southampton in 2026
GLS: P3
Working hours: 37.5 Hours Weekly
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:
As the Senior Regulatory Affairs Specialist on our Regulatory Intelligence team, you will offer global expertise in regulatory intelligence, covering regulatory affairs, pre-clinical, clinical, and commercial aspects for both investigational and marketed products.
Your responsibilities will include providing regulatory and competitive intelligence, conducting scientific and regulatory information searches, summarizing findings, and disseminating this information to the business. Additionally, you will proactively monitor emerging scientific and regulatory trends, approvals, and strategies to inform and shape the development of regulatory strategies and policies across various portfolio areas.
Key Responsibilities:
1. Develop and execute a regulatory intelligence strategy. Stay updated on internal and external changes affecting regulatory and access strategies, and propose action plans.
2. Interpret complex scientific issues related to regulatory requirements, intelligence, policy, and strategy for the region. Experience with a major regulatory agency or in government affairs/policy is desired.
3. Follow regulatory plans and collaborate with internal and external project team members to complete corporate regulatory initiatives.
4. Liaise with internal functions (QA, Operations, Manufacturing, Professional Services, Legal, RA, Marketing) to provide necessary information and documentation.
5. Collect regional regulatory intelligence and provide monthly reports. Monitor regulatory changes and notify relevant personnel.
6. Maintain regulatory files and tracking documents. Communicate status updates with supervisors and other departments.
7. Assess and maintain procedures for documents of external origin (standards, regulations, guidance) and regulatory intelligence.
8. Prepare new/revised regulatory requirements for CooperVision site Management Reviews.
9. Prepare MDSAP Chapter 2 data for CooperVision MDSAP sites in preparation for audits.
About you:
We are seeking a candidate with exceptional collaboration, relationship-building, influencing, and negotiation skills. The ideal candidate will also possess a working knowledge of US regulations and guidance, including but not limited to FDA 21 CFR, MDSAP, ISO 13485, UKCA, MedDO, MDD, and MDR.
Experience & Education:
Required:
1. 1-5 years of regulatory intelligence experience.
2. Ability to develop a deep understanding of health authority operations, regulatory requirements, and the interpretation of regulatory guidelines.
3. Comprehensive knowledge of regulations and guidance governing medical devices throughout all phases of development, including post-marketing, in the US and/or EU, with a solid grasp of basic regulatory requirements in emerging markets.
4. Familiarity with database-oriented software and/or Agile PLM (Product Lifecycle Management) and global RA database reporting functions.
5. Strong overall capabilities, with the ability to train and develop staff in regulatory intelligence. This includes understanding broad concepts within regulatory affairs and their implications across the organization and globally, as well as proactively identifying regulatory trends.
6. Proficiency in understanding and interpreting complex scientific issues across projects as they relate to regulatory requirements, regulatory intelligence, and regional strategy.
7. Bachelor's Degree required; an advanced scientific-related degree is preferred.
What we offer:
You'll receive competitive compensation and a fantastic benefits package including; 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, flexible working, 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 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.
We operate a candidate referral scheme, so if you know anyone who could be a perfect fit for this role, please email their CV to referafriend@coopervision quoting the job reference code to enjoy a £100 voucher reward if they are successful!
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 a diverse, inclusive, 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.
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