Regulatory Affairs Coordinator

Medasource; Blue Ash (OH); On-site; USD 60,000 - 85,000; Full time

Job summary

Medasource in Blue Ash, OH is seeking a regulatory submissions specialist to prepare and submit FDA CFG requests and manage regulatory document workflows for medical device registrations.

You will coordinate notarization, apostille, and legalization of documents, ensure traceability, and collaborate with offshore teams to support inquiries from inspection through approval.

Qualifications

• Experience with regulatory documentation workflows.
• Ability to coordinate multiple stakeholders.
• Strong attention to detail and record-keeping.

Responsibilities

• Prepare and submit requests to the FDA for Certificates of Foreign Government (CFG), and any task/process requiring a U.S.-based resource.
• Coordinate notarization, apostille and legalization of regulatory documents as necessary.
• 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 regulatory compliance requirements are met.

Skills

FDA regulatory submissions

Document control

Cross-functional coordination

Attention to detail

Job description

Contract Length: 1+ year contract with high potential for extensions

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