Regulatory Affairs Coordinator

Job Title: Regulatory Coordinator

Contract Length: 1+ year contract with high potential for extensions

Location: Raritan, NJ onsite 5 days per week

Hours: 40

Start Date: ASAP



Job Description:


- Prepare and submit requests to the FDA for Certificates of Foreign Government (CFG), and any task/process requiring a U.S.-based resource
- Prepare/review and coordinate routing of documents requiring Company’s representative’s signatures
- Coordinate notarization, apostille and legalization of regulatory documents as necessary
- Together with the Service Provider’s Offshore Project Manager, verify offshore deliverables
- Coordinate the preparation and submission of medical device applications by providing regulatory information to support all types of international registrations and following up closely on queries from inspection through approval
- Demonstrate attention to details and working knowledge of good documentation practices including, but not limited to, proof reading, formatting, indexing, record keeping, etc.
- Ensure accuracy checks and consistency of documents intended for submissions
- With minimal oversight, prepare/review letter of authorizations, cover letters for certificates, declaration of conformity, latex free letters, etc.
- Provide assistance to all regions with data/document/information retrieval from searching through internal Company tools
- Coordinate across cross-functional Company departments to provide requested information to assist technical inquiries
- Maintain tracking tools for traceability of all regulatory data/documentation
- Provide accurate and on-time deliverables to ensure local regulatory compliance requirements are met
- Assist the Team Manager with triage of requests from Company’s systems and assignment to the appropriate Service Provider’s or Company’s fulfiller/team