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Senior principal regulatory affairs specialist (senior manager)

Herstal
CooperVision
Publiée le 8 octobre
Description de l'offre

Overview

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. A brighter future awaits you. CooperVision is a global leader in the contact lens industry with a presence in over 100 countries. We aim to improve how people see every day and to create an inclusive, engaging workplace where every employee can grow. Job responsibilities

Develop and implement regulatory strategies for corporate projects. Provide expert guidance to cross-functional teams in partnership with senior stakeholders. Lead registration activities and maintain regulatory documentation systems. Monitor regulatory changes and communicate impacts across the business. Review and approve product labeling 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. Work to protect and grow the business through proactive regulatory leadership and strong commercial partnerships. Travel locally and internationally – approximately 20%. About you

We are looking for someone with strong leadership qualities who can 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 to ensure compliance and drive quality excellence. Qualifications

Exceptional attention to detail, strong organizational and technical writing skills. Proficiency in MS Office and relational database systems. Ability to thrive in multinational and multicultural environments. Excellent communication skills and ability to manage multiple priorities. 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 comprehensive benefits package including car allowance, bonus, private medical insurance, 25 days holiday, pension scheme, healthcare cover, life assurance, access to Wellness Platform for mental health and wellbeing, discounted contact lens scheme, and more. We support personal and professional development with extensive training, LinkedIn Learning access, and opportunities to grow within CooperVision. What you can expect

As a CooperVision employee, you’ll join a diverse, global team that values inclusion. We strive to create an inclusive culture where different perspectives add value and contribute to our success. If you like what you see, apply today. All suitably qualified applicants will receive equal consideration and opportunities from CooperVision. About Us

CooperVision is a global leader in the contact lens industry, focused on helping people see better every day. We are committed to developing people as a key differentiator and asset, rewarding great thinking and hard work with competitive pay and benefits, and supporting wellness throughout the organization. Additional information

Seniority level: Mid-Senior level Employment type: Full-time Job function: Education and Training Industries: Medical Equipment Manufacturing

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