Senior Principal Regulatory Affairs Specialist (Senior Manager)

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Senior Principal Regulatory Affairs Specialist (Senior Manager), Milan

Job description:

Position:

Senior Principal - Regulatory Affairs Specialist (Senior Manager)

Department:

Regulatory Affairs

Locations:

• Delta Park, Segensworth / Hybrid (moving to Southampton in May 2025)
• Madrid, Spain / Hybrid
• Sophia Antipolis, France / Hybrid
• Milan, Italy / Hybrid
• Gorinchem, Netherlands / Hybrid

Company:

CooperVision - a leading manufacturer of soft contact lenses, present in over 100 countries.

Company Values:

We promote inclusion, diversity, and a sense of belonging. We aim to create an inclusive and engaging workplace where everyone can grow.

Job Summary:

Lead global regulatory strategies across EMEA regions, collaborating with commercial leadership, and supporting market access and regulatory compliance from product conception to launch.

Key Responsibilities:

• Develop and implement regulatory strategies for projects
• Provide guidance to cross-functional teams
• Lead registration activities and maintain documentation systems
• Monitor regulatory changes and communicate impacts
• Review 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
• Travel approximately 20% for local and international trips

Candidate Profile:

Strong leadership, influence, and deep understanding of regulatory frameworks (ISO 13485, MDSAP, MDD, MDR). Attention to detail, organizational skills, and ability to operate in multicultural environments are essential. Excellent communication skills and multitasking ability are required.

Qualifications and Experience:

• Bachelor’s degree in a scientific or technical discipline
• 8-12 years in the regulated medical device industry
• Experience with regulatory submissions and technical documentation
• Proven track record managing complex projects and audits
• Experience with electronic document management systems
• Regulatory Affairs Certification and advanced degrees are a plus

What We Offer:

Competitive salary, benefits including car allowance, bonus, private medical insurance, 25 days holiday, pension, healthcare, life assurance, wellness platform, contact lens scheme, and professional development opportunities.

Our Commitment:

We value diversity and inclusion, fostering an environment where everyone can thrive and contribute to our success.