Regulatory Affairs Associate
Eurofins2 days ago
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OnsiteFull-timeMid
Summary
Eurofins is seeking a Regulatory Affairs Associate to join their team in Kalamazoo, MI. The role involves supporting regulatory submissions and compliance for Human Health and Animal Health Diagnostics Groups.
About the Role
As a Regulatory Affairs Associate, you will assist in preparing and reviewing regulatory documentation for medical devices, ensure compliance with FDA and international regulations, collaborate with business partners for timely document processing, and manage regulatory activities and timelines. You will also assess product changes for regulatory impact and work with cross-functional teams to meet project needs.
About You
Required:
- Authorization to work in the United States indefinitely without restriction or sponsorship.
- Minimum of BS/BA in a relevant discipline such as regulatory affairs or biology.
- 3-5 years direct experience in human health In Vitro Diagnostics and/or Animal Health Diagnostics.
- Strong verbal and written communication and organizational skills.
- High level of competency using Microsoft Office suite, Microsoft Word, Excel, and Adobe Acrobat.
Preferred:
- Knowledge of SAP, Veeva Vault, and Trackwise.
- Attention to detail to ensure all expectations for regulatory documents are met.
- Flexibility and capacity to handle multiple tasks at once.
Benefits
- Comprehensive medical coverage, dental, and vision options.
- Life and disability insurance.
- 401(k) with company match.
- Paid vacation and holidays.
Eurofins
Since 1987, Eurofins has grown from one laboratory in Nantes, France to over 65,000 staff across a network of independent companies in 60 countries, operating over 950 laboratories. Performing over 450 million tests every year, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing. Ever since its IPO on the French stock exchange in 1997, Eurofins has been one of the fastest growing listed European companies.
Kalamazoo, MI