Principal Regulatory Affairs Specialist (FTC)
Principal Regulatory Affairs Specialist (FTC)
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Job Description
Job title: Principal Regulatory Affairs Specialist (12 Month FTC commencing in October 2025)
Department: Regulatory Affairs
Location: Delta Park Fareham (moving to Adanac Park Southampton in May 2026) / Hybrid
GLS: P04
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.
At CooperVision were big on belonging. Everyones contribution counts and thats why inclusion and diversity are so isnt just the right thing to do; its 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 lets achieve amazing things together.
Job summary What to expect:
Were seeking a highly experienced Principal Regulatory Affairs Specialist to lead regulatory strategy and ensure compliance andshapingmarket access and regulatory strategy across EMEA.
In this pivotal role youll drive global and regional regulatory processes shape procedures for marketed products and maintain our regulatory excellence to PROTECT the business;GROWthe youre passionate about navigating complex regulations and making a global impact wed love to hear from you.
Essential Functions & Accountabilities:
- Lead and approve regulatory submissions for product registrations across assigned regions ensuring timely and accurate documentation management.
- Maintain up-to-date knowledge of regional regulatory requirements and communicate changes and impacts to internal stakeholders.
- NK2Represent Regulatory Affairs in cross-functional initiatives providing expert input on labelling product documentation and compliance.
- Support audits and regulatory inspections across UK EU ACE and MENA regions.
- Mentor junior team members and contribute to departmental initiatives and continuous improvement efforts.
- Act as a regulatory resource for quality issues risk mitigation and public policy representation.
- Independently manage multiple projects and daily tasks ensuring alignment with business and compliance objectives.
- Travel requirements (local and international) approximately 20%
A full job description is available upon request.
About you:
We are looking for someone who has proven experience in building relationships across a diverse business and the capability to interact effectively and credibly at senior levels. Experience in electronical document management systems is required as well as the ability to read and understand technical material.
Experience & Education:
- Bachelors degree in a scientific or technical discipline and working knowledge of medical device regulations.
- 6-8 years of medical device regulatory experience.
- Understanding of ISO 13485 requirements and EU medical device regulations.
- Medical device industry experience including strong working knowledge and experience with MDD and MDR.
- Technical writing experience. Has experience evaluating manufacturing changes for impact on global regulatory affairs submissions.
- Experienced at reviewing and approving product labelling.
- Ability to operate in a business-driven model providing quick salient analysis and concrete action plans emphasis on understanding and anticipating business needs and interests and devising proactive approaches/responses.
What we offer:
Youll receive competitive compensation and a fantastic benefits package including; bonus 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 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. With our CooperPride African Descent Womans 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.
Please view our careers page at view all other opportunities.
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Required Experience:
Staff IC
Employment Type
Full-Time
