Regulatory 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

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

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

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