QualificationsFDA regulationsMaster’s degree
Be the single threaded owner for all regulatory needs related to health technology research
Help define and drive regulatory strategy for new product development, with the goal of commercializing new health technologies
Demonstrate the ability to develop a variety of solutions to regulatory challenges
Exercise independent judgement in setting and communicating appropriate regulatory action and requirements
Be the single threaded owner for communication with regulatory agencies for product filings, clearances and strategies
Masters degree in science related field, or equivalent experience
10+ years of device approval experience in a regulatory affairs role, with 5+ years experience as a principal, manager or lead
Experience with software as a medical device (SaMD) development, managing audits from regulatory authorities, and taking submissions through regulatory approvals
Direct experience in leading interactions with US regulatory health authorities
Knowledge of global regulatory health authorities
Experience working at the FDA and/or experience with digital health technologies
Experience conducting Pre-Submission or Q-Submission program at FDA
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