Regulatory Affairs Senior Specialist
CooperCompaniesDenmark • Barcelona, Catalonia, Spain
Posted September 18, 2025
Full Time
About the Company
CooperCompanies (Nasdaq: COO) is a global medical device leader with two business units: CooperVision, which specializes in contact lenses; and CooperSurgical, focused on fertility and women's healthcare. The company operates in over 130 countries, impacting fifty million lives annually through innovative products like IVF devices and vision correction solutions. Known for its dedication to innovation, health and wellness, and community support, CooperCompanies is recognized as a U.S. Great Place to Work and is committed to meeting evolving healthcare needs.
Job Description
CooperSurgical is seeking a Regulatory Affairs Specialist to join their Global Regulatory Affairs team in Denmark or Spain. This role focuses on US, Canadian, and Australian markets, ensuring compliance and supporting submissions for their fertility and women’s health solutions. The position requires collaboration with diverse teams and proactive planning in a fast-paced environment.
Requirements
- Lead regulatory activities for US, Canadian and Australian markets.
- Prepare, submit, and maintain files and legalized documentation.
- Perform regulatory assessments of product changes (letter-to-file / not-to-file decisions).
- Manage annual renewals, license maintenance, and regulatory notifications.
- Support the preparation of 510(k) submissions.
Benefits
- Opportunities for professional growth
- Inclusive and international work environment
- Positive workplace culture
- Dynamic, high-growth global leader
