Senior Principal Regulatory Affairs Specialist (Senior Manager)

CooperCompanies; Valbonne; Hybride; EUR 80 000 - 100 000; Plein temps

Résumé du poste

A leading global medical device company in Valbonne is seeking a Senior Principal- Regulatory Affairs Specialist to develop global regulatory strategies. The ideal candidate will have extensive experience in regulatory affairs and will work closely with various teams. This role offers competitive compensation, an inclusive workplace, and a focus on personal development.

Prestations

Car allowance

Private medical insurance

25 days holiday

Pension scheme

Access to a Wellness Platform

Qualifications

• 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.

Responsabilités

• Develop and implement regulatory strategies for corporate projects.
• Provide expert guidance to cross-functional teams.
• Lead registration activities and maintain regulatory documentation.

Connaissances

Attention to detail

Organizational skills

Technical writing

Communication skills

Formation

Bachelor's degree in a scientific or technical discipline

Outils

MS Office applications

Relational database systems

Electronic document management systems

Description du poste

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.

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 expert – 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.

Responsibilities

• 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 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 an inclusive culture is and how different perspectives add value and contribute to our success.