- Assure accurate data entries for Human Health Products
- Collaborate with the Global Product Dictionary Admin team to assure Global Diagnostics system needs are met
- Facilitate release of product shipments within the ERP system when Regulatory approvals are obtained– Regulatory Affairs Documentation Support:
- Coordinate with Regulatory Affairs Managers and Manufacturing Compliance Members to obtain legalization of documents required for International Markets
- Gather manufacturing documents and other documents needed to support registration as requested by the regulatory team
- Upload required documents into the Enterprise-wide Document Management System
- Maintains information systems (electronic and paper) for regulatory information– Assist in the development of instructional guidance’s and processes, as applicable – Provide status updates on tasks as appropriate
- Label Backup Support (in support of the primary diagnostic label lead):
- Liaise with Regulatory Affairs managers, icRAMS and the Client Artwork Center to assure compliance with global diagnostics labelling requirements
- Manage study risk assessments process including risk assessment intake, assignment, compilation, signatures, and final archival
- A degree in Science, Pharmacy, or related business
- Knowledge or experience of Diagnostics products and Regulatory Affairs preferred.
- At least one year experience working in Veterinary / Human Regulatory Affairs environment.
- Experience working in a dynamic multicultural environment and working with colleagues based in multiple countries.
Position is full-time, first shift, Monday-Friday 8AM-5PM. Candidates currently living within a commutable distance of Kalamazoo, MI are encouraged to apply.
What we offer:
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Yearly goal-based bonus & eligibility for merit-based
- #LI-EB1
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
