Sr Regulatory Affair Principal

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Not verified last checked Jun 13, 2026

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401(k) match

Listed Source: EMPLR_CONTRIB_INCOME_AMT. source Last checked Jun 13, 2026.

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About this role

Sr Regulatory Affair Principal Somerville, Massachusetts Responsibilities Job Title: Sr. Regulatory Affairs Principal Reports to: Head of Quality & Regulatory FLSA Status: Exempt Job Summary Working 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

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