Regulatory Affairs Manager

Position Summary:

This position will be responsible for regulatory activities related to the development and implementation of  regulatory strategies to support the submission and filing of multiple indications (clinical applications or “apps”) in Dermatology and Oncology medical device products in targeted markets. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with FDA and corporate partners with regulatory deliverables. In addition, this position will require direct and hands on experience to support the development and implementation of FDA QSR and ISO 13485: 2016 QMS, and applicable international regulatory compliance activities.Under the direction of Associate Research Scientist, conduct in vitro and in vivo pre-clinical research to optimize the stimulation of the immune system using the Nano-Pulse Stimulation Platform. Conduct additional pre-clinical research where the data indicates further research.



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All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.