Sr Regulatory Affair Principal
ResponsibilitiesJob Title: Sr. Regulatory Affairs Principal
Reports to: Head of Quality & RegulatoryFLSA Status: Exempt Job SummaryWorking cross-functionally with the Research and Development – ProFound team, the Sr. Regulatory Affairs Principal is responsible for developing and executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth’s high risk products, including AI technologies. This position will provide regulatory input on design and development activities to cross-functional teams, to ensure compliance with the relevant regulatory requirements and interactions with regulatory authorities. Essential Duties and Responsibilities As the Sr. Regulatory Affairs Principal, this position will: Develop and execute the regulatory strategy for DeepHealth’s high risk (FDA Class III) devices. Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for high risk medical devices. Lead and manage regulatory submissions, including FDA Q-submission, US 510(k)s submissions, Premarket Approvals (PMA) submissions, supplements, and reports, including Regulatory Body interactions. Work closely with business partners and regulatory team members to ensure compliance for and support of regulatory submissions and filings. Monitor and interpret evolving global regulations, standards, and guidance documents to ensure the company’s regulatory compliance, translating them into action steps for the organization. Create and ensure maintenance of technical documentation as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products PLEASE NOTE: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time. Minimum Qualifications, Education and Experience Bachelor’s degree in a life science, engineering, or related scientific field is required. An advanced degree or Regulatory Affairs Certification is preferred. 13 - 17 years working in a regulated industry (FDA and Software as a Medical Device preferred). Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, Traditional 510(k) filings, and Premarket Approval for Software as Medical Device. Experience with US FDA Class III devices required; OUS device classification preferred. Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, product Deficiency Response meetings, and regulatory inspections. Experience with FDA’s Total Product Life Cycle Advisory Program (TAP) and Breakthrough Designation a plus. International submission experience in Australia, Canada, Brazil, and Japan for high risk devices Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56. Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred. Excellent written and oral communication skills Physical Demands This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation. Working Environment Remote. This position requires domestic / international travel up to 15%. apply to this job