FDA Regulatory Submissions Coordinator

Medasource; Blue Ash (OH); On-site; USD 28,000 - 41,000; Full time

Job summary

Medasource supports a Fortune 500 Med Tech company in a regulatory coordination role in Ohio. The position focuses on preparing and submitting regulatory documents, managing document flow, and ensuring accuracy for all submissions.

Expect close interaction with cross-functional teams and time-sensitive delivery. Responsibilities include FDA CFG requests, notarization and legalization, and ensuring readiness for international registrations.

Qualifications

• Experience handling regulatory submissions and FDA-related activities.
• Strong attention to detail and documentation practices.
• Ability to coordinate across multiple departments and regions.

Responsibilities

• Prepare and submit FDA CFG requests and related US-based tasks.
• Review routing of signatures and coordinate document flow.
• Coordinate notarization, apostille, and legalization of regulatory docs.
• Verify offshore deliverables with Offshore PM.
• Support international registrations and follow-up on inspection queries.
• Maintain clear, accurate documentation and indexing for submissions.
• Prepare letters of authorization and cover letters for certificates.
• Assist regions with data retrieval using internal tools.
• Coordinate cross-functional info for technical inquiries.
• Track regulatory data/documentation for traceability.
• Ensure timely, compliant deliverables for local regs.
• Assist Team Manager with triage and task assignment.

Skills

Regulatory submissions

FDA processes

Document control

Cross-functional coordination

Notarization & legalization

Job description

Medasource supports a Fortune 500 Med Tech company in a regulatory coordination role in Ohio. The position focuses on preparing and submitting regulatory documents, managing document flow, and ensuring accuracy for all submissions.

Expect close interaction with cross-functional teams and time-sensitive delivery. Responsibilities include FDA CFG requests, notarization and legalization, and ensuring readiness for international registrations.