Regulatory Coordinator

Medasource; Raritan (NJ); On-site; USD 28,000 - 41,000; Full time

Job summary

Medasource is seeking a regulatory support specialist for a Fortune 500 medical technology client in Raritan, NJ. This contract role (6 months to 1 year) involves preparing and submitting FDA CFG requests and coordinating regulatory documentation for international registrations.

You will ensure accuracy, manage document routing for signatures, oversee notarization and apostille where needed, and maintain traceability of regulatory data while supporting cross‑functional teams.

Qualifications

• Attention to detail and good documentation practices.
• Experience coordinating regulatory submissions and document reviews.
• Ability to retrieve data from internal systems and support inquiries.

Responsibilities

• Prepare and submit CFG requests to FDA for regulatory compliance.
• Coordinate routing of documents requiring signatures.
• Coordinate notarization, apostille, and legalization of regulatory docs.
• Verify offshore deliverables with offshore PM.
• Support international registrations with regulatory information.
• Maintain traceability tracking tools for regulatory data.
• Provide timely deliverables to meet local regulatory requirements.
• Assist with triage of requests within systems.

Skills

Regulatory coordination

Documentation accuracy

FDA CFG submissions

Cross-functional collaboration

Attention to detail

Job description

Hourly/Salary Compensation Range: ~ $20-30/hr

Contract Length: 6 months-1 year, potential for extension

Location: Raritan, NJ

Hours: 40/week

Start Date: ASAP

Client Description: Fortune 500 Med Tech Company

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