Regulatory Affairs Coordinator

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

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