Senior Regulatory Affairs Specialist – Regulatory Intelligence

CooperVision

  • Southampton
  • Permanent
  • Full-time
  • 13 days ago
Job Category: Compliance, Risk & LegalJob Description:Job title: Regulatory Affairs Specialist/Senior Regulatory Affairs SpecialistDepartment: Regulatory AffairsLocation: Delta Park, Fareham (moving in Southampton in May 2026) / HybridGLS: P02/P03Working hours: 37.5 WeeklyA brighter future awaits youCooperVision 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.Job summary - What to expect:As a Regulatory Affairs Specialist/Senior Specialist - Regulatory Intelligence, you'll play a pivotal role in supporting CooperVision's Contact Lens and Contact Lens Care business. You'll collaborate across a wide range of global, regional, and local teams - including Regulatory Affairs, Quality Systems, Clinical, Professional Services, R&D, Marketing, and Manufacturing. You'll 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 SpecialistFocus: 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 SpecialistFocus: 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:You'll 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, we'll 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 CooperVisionWhat 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.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 to view all other opportunities.#INDHP#LI-ONSITE #LI-HYBRID #LI-LD2About 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 an 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.

CooperVision