Job Description
Job title: Senior Principal- Regulatory Affairs Specialist (Senior Manager)
Department: Regulatory Affairs
Multiple Locations Available:
* Delta Park, Segensworth moving to Southampton in May 2025 / Hybrid
* Madrid, Spain / Hybrid
* Sophia Antipolis, France / Hybrid
* Liege, Belgium / Hybrid
* Milan, Italy / Hybrid
* Gorinchem, Netherlands / Hybrid
* Goeteborg, Sweden / Hybrid
GLS: P5
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[NK1] .
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:
Are you ready to make a global impact in regulatory affairs? Join us as a Regulatory Affairs Senior Principal and become a key player in shaping market access and regulatory strategy across EMEA - including the EU, CIS, ACE and MENA regions.
In this role, you will be more than just a regulatory expect - you will be a business partner where you will lead global strategy from product conception through to launch and beyond. You will collaborate closely with the EMEA Commercial leadership team, delivering pragmatic solutions, creative leadership strategy and being a champion of the Regulatory Affairs mission: PROTECT the business; GROW the business.
Essential Functions & Accountabilities:
* Develop and implement regulatory strategies for corporate projects
* Working in partnership with senior stakeholders, provide expert guidance to cross-functional teams
* Work collaboratively with the internal team to ensure a one voice in regards to requirements.
* Lead registration activities and maintain regulatory documentation systems
* Monitor regulatory changes and communicate impacts across the business
* Review and approve product labelling and marketing materials
* Support private label and own-brand customers, liaising with EU authorities
* Collaborate with global teams in packaging, supply chain, QA, and R&D
* Mentor junior team members and represent the company with regulatory bodies
* You'll be part of a mission to protect and grow the business through proactive regulatory leadership and strong commercial partnerships.
* Travel requirements (local and international) - approximately 20%
A full job description is available upon request.
About you:
We are looking for someone who demonstrates strong leadership qualities and can effectively influence decision-makers across the business. You will bring a deep understanding of regulatory frameworks including ISO 13485, MDSAP, MDD, MDR, and other relevant standards, ensuring compliance and driving quality excellence.
To succeed in this role, you'll need:
* Exceptional attention to detail, with strong organizational and technical writing skills.
* Proficiency in MS Office applications and relational database systems.
* The ability to thrive in multinational and multicultural environments.
* Excellent communication skills and the capability to manage multiple priorities simultaneously.
Experience & Education:
* Bachelor's degree in a scientific or technical discipline required.
* 8-12 years of experience in the regulated medical device industry.
* Extensive experience with regulatory submissions and technical documentation.
* Proven track record of managing complex regulatory projects and audits.
* Experience in electronic document management systems.
* Advanced degree and Regulatory Affairs Certification highly desirable
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, 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 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.
#INDHP
#LI-HYBRID #LI-LD2
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 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. #J-18808-Ljbffr