Regulatory Affairs Specialist II
CooperCompaniesConnecticut, United States • New Jersey, United States
Posted September 25, 2025
75000 - 100000 USD year
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 a leading fertility and women’s healthcare company seeking a Regulatory Affairs Specialist II to manage product regulations, prepare filings, and coordinate interactions with regulatory bodies in the US, EU, and other regions. The role involves ensuring compliance with regulations and contributing to the development of regulatory strategies. CooperSurgical offers a supportive environment focused on empowering patients and enabling life's moments.
Requirements
- Experience with Regulatory Affairs (2-5 years preferred)
- Experience with 510(k) submissions, Technical File Experience (4-5 years preferred)
- Knowledge of US, EU MDR/IVDR, Health Canada requirements
- Bachelor’s degree from a four-year college or university or equivalent experience
Benefits
- Medical coverage
- 401(k)
- Parental leave
- Fertility benefits
- Paid time off
- Personal, sick, and holiday time
- Multiple perks and benefits