Sr. Regulatory Affairs Spclst

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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 Affairs Spclst Somerville, Massachusetts Responsibilities Job Title: Sr. Regulatory Affairs Specialist Reports to: Quality and Regulation Leader FLSA Status: Exempt Job Summary The Sr. Regulatory Affairs Specialist is responsible for supporting DeepHealth's product and product development and regulatory activities to commercialize new digital products, including AI technologies. In this role, the Sr. Regulatory Specialist 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 Specialist, this position will: · Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. · Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance. · Assist in SOP development and review in support of "next-gen" product offerings. · Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. · Understand and investigate regulatory history/background of class, disease/ therapeutic context in order to assess regulatory implications for approval. · Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products · Assist in preparation and review of regulatory submission to authorities. · Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action. · Utilize technical regulatory skills to propose

Read the full description at careers-radnet.icims.com. FewerJobs shows a source-linked preview and links to the original posting.