Sr. Regulatory Affairs Spclst

About the Role

The Sr. Regulatory Affairs Specialist supports DeepHealth’s product development and regulatory activities to commercialize new digital products, including AI technologies. This role provides regulatory input on design and development activities to cross-functional teams, ensuring compliance with relevant regulatory requirements and interactions with regulatory authorities.

Responsibilities

• 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 to assess regulatory implications for approval.
• Create and ensure maintenance of technical documentation (e.g., clinical evaluation reports, risk management reports, 510(k) notifications) required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products.
• Assist in preparation and review of regulatory submissions 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.
• Provide limited work direction and guidance to peers and/or skilled non-exempt employees.
• Participate in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
• Work with clinical teams to ensure compliance for pre- and post-market clinical studies in support of DeepHealth products and product changes.
• Ensure timely submission of adverse events to the appropriate regulatory bodies.

This is not an exhaustive list of duties; other functions may be assigned.

Requirements

• Bachelor’s degree in a relevant field (or equivalent experience).
• 8–12 years of experience working in a regulated industry (FDA and Software as a Medical Device preferred).
• Strong knowledge of FDA Quality System Regulations, including 21 CFR 11 and 21 CFR 820.
• Experience drafting and submitting regulatory filings, including Q-Submission requests, Traditional and Special 510(k) filings for Software as a Medical Device.
• Experience with US FDA Class I and II medical devices; additional experience with FDA Class III devices and OUS device classification is a plus.
• Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, product Deficiency Response meetings, and regulatory inspections.
• Knowledge and understanding of pre- and post-market clinical studies, including 21 CFR 812, 21 CFR 50, and 21 CFR 56.
• Knowledge of Medical Devices Regulations (MDR 2017/745, MDCG 2019-11, MDCG 2020-1), ISO 13485, MDSAP, ISO 14971, ISO 62366, IEC 82304-1, and IEC 62304 (preferred).
• Excellent written and oral communication skills.

Physical Demands

• 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.
• Must be able to lift up to 10 pounds occasionally.
• Ability to travel (~10% of the time).

Working Environment

Remote.