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RadNet · 1 day ago

Sr Regulatory Affairs Principal Autonomous

Somerville, MA

Full-time

Hybrid

Senior Level, Lead/Staff

13+ years exp

RadNet is a leader in healthcare technology, and they are seeking a Sr. Regulatory Affairs Principal to develop and execute regulatory strategies for high risk products, including AI technologies. The role involves ensuring compliance with global regulations and leading the process to obtain and maintain market approval for medical devices.

Health CareHealth DiagnosticsHospitalMedical

No H1B

Responsibilities

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

Qualification

Regulatory strategy developmentFDA Class III devicesRegulatory submissions managementFDA Quality System RegulationsInternational submission experienceMedical Devices Regulations knowledgeProfessionalismCommunication skillsTeam collaborationInitiative

Required

Bachelor's degree in a life science, engineering, or related scientific field is required

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

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

Excellent written and oral communication skills

Preferred

An advanced degree or Regulatory Affairs Certification is preferred

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 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