FDA Regulatory Submissions 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

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.