Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provides regulatory guidance to the project teams.
Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.
Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval.
Maintain regulatory documentations to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents.
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