Regulatory Affairs Coordinator

Medasource; Raritan (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Medasource in Raritan, NJ seeks a regulatory associate to prepare and submit FDA requests, coordinate document routing for sign-offs, and manage regulatory submissions across regions. You will ensure good documentation practices and maintain traceability for regulatory data.

Working onsite five days a week, you will support cross-functional teams, handle notarization, apostille, and ensure timely, compliant deliverables with minimal supervision.

Responsibilities

• 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 authorization, 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

Job description

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