Sr Regulatory Affairs Principal Autonomous

Responsibilities

Job Title: Sr. Regulatory Affairs Principal (Autonomous)

Reports to: Head of Quality & Regulatory

FLSA Status: Exempt

Job Summary: Working cross-functionally with the Research and Development – Pro Found 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 Deep Health’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.

• Develop and execute the regulatory strategy for Deep Health’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 Deep Health 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.

• 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.

• Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co‑workers, patients, visitors, and vendors.
• Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
• Follows all local, state and federal laws concerning employment to include but not limited to: I‑9, Harassment, EEOC, Civil rights and ADA.
• Follows OSHA regulations, Rad Net and site protocols, policies and procedures.
• Follows HIPAA, compliance, privacy, safety and confidentiality standards at all times.
• Practices universal safety precautions.
• Promotes good public relations on the phone and in person.
• Adapts and is willing to learn new tasks, methods, and…