Regulatory Affairs Associate
Eurofins Scientific is seeking a Regulatory Affairs Associate to join our Human Health and Animal Health Diagnostics Groups. This role focuses on regulatory submissions and compliance, ensuring our diagnostic products meet global regulatory standards. Eurofins is an international life sciences company dedicated to providing analytical testing services across various industries to promote safety, health, and sustainability.
The Regulatory Affairs Associate will assist in preparing and reviewing regulatory documentation for medical devices, including 510(k) submissions, CLIA Waivers, and Technical Files. Responsibilities include ensuring compliance with FDA, EU In Vitro Diagnostic Device Regulation, and other international regulatory requirements, as well as assessing product changes for potential global regulatory impact. The role also involves collaborating with cross-functional development teams to meet regulatory project needs and managing accurate timelines for deliverables.
Candidates should possess a BS/BA in a relevant discipline such as regulatory affairs or biology, along with 1-3 years of direct experience in human health In Vitro Diagnostics and/or Animal Health Diagnostics. Preferred qualifications include knowledge of SAP, Veeva Vault, and Trackwise. Strong verbal and written communication skills, proficiency in Microsoft Office Suite and Adobe Acrobat, and the ability to handle multiple tasks are essential. The ideal candidate will demonstrate accountability, approachability, and the capacity to work independently while fostering good working relationships across physical distances.
This full-time position offers comprehensive benefits, including medical, dental, and vision coverage, life and disability insurance, a 401(k) plan with company match, and paid vacation and holidays. The role is based in Kalamazoo, MI, with working hours from Monday to Friday, 8:00 am to 5:00 pm. Candidates residing within a commutable distance are encouraged to apply.
Eurofins fosters a collaborative and dynamic work environment, emphasizing professional growth and development. Joining our team provides the opportunity to contribute to meaningful projects that impact global health and safety, supported by a company committed to innovation and excellence.