Global Dx Regulatory Affairs Coordinator
Global Dx Regulatory Affairs Coordinator
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- 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 Enterprisewide Document Management System
- Maintains information systems (electronic and paper) for regulatory information Assist in the development of instructional guidances 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
Qualifications :
- 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.
Additional Information :
Position is fulltime first shift MondayFriday 8AM5PM. 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 goalbased bonus & eligibility for meritbased
- #LIEB1
Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
