• 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 strategies on complex issues. • Ensure compliance with product post marketing requirements. • Review product labeling to ensure compliance with relevant regulatory requirements. • Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. • Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. • Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of DeepHealth products and product changes. • Ensuring timely submission of adverse events to the appropriate regulatory bodies.