Ensure regulatory compliance of the company and product at all times: Recording country speci?c regulatory submissions by compiling submissions in a format consistent with applicable U.S. FDA guidance documents, technical writing, and analysis to support implementing quality assurance procedures for compliance, documenting device requirement speci?cations and planning and leading ISO 13485:2016 audits.
Bringing the product to market through regulatory clearance (U.S. FDA): Work across all teams by giving strategic and regulatory advice and support, making important contributions commercially, technically, and scienti?cally to the success of the product’s commercialization.
Documentation of current regulations: Have a close eye on changes in medical regulations and immediately document the relevant change in device regulations, additionally collect, collate, and evaluate scienti?c data.
Document management: Maintain and update all the quality assurance and regulatory documentation, wherever and whenever necessary. Should work on managing and documenting information, and must be adept at working with databases and other information management tools.
Interaction with regulatory bodies: Assist in preparing responses to regulatory authorities within assigned timelines to stay abreast of regulatory procedures and changes in the regulatory climate.
Device comparable research: Develop strategies to search for comparable devices in the market of interest for commercialization.
Build case studies and arguments: Should be able to infer from the regulations and build use cases, and arguments for the device under consideration.