Digital Health Regulatory Affairs Manager
Core
Develop strategies to obtain FDA clearance or approval for new Class II & III cardiovascular medical devices and improvements to existing devices, serving as a liaison for global regulatory teams.
Role type
Regulatory Affairs Manager (Digital Health)
Builds
Cardiovascular medical devices including Heart Pumps, cardio-renal unloading systems, and ECMO solutions with integrated software and AI/ML components.
Domain
Medical Devices / Digital Health / Cardiovascular
Deliverable
production ML models | product features
Required skills
Regulatory strategy, FDA submissions (510(k), PMA, IDE), Cybersecurity (524B), Software as a Medical Device (SaMD), Systems Engineering, Global regulatory compliance, Technical problem solving
Preferred skills
Engineering degree, Class III device experience, FDA review experience, RAC certification, AI/ML experience
Technologies
SaMD, SiMD, AI/ML, IEC 62304, ISO 13485, ISO 14971, Cybersecurity 524B
Responsibilities
Prepare and review FDA submissions, interact with FDA reviewers during pre-submission and review periods, advise on global regulatory requirements, support cross-functional new product development projects, provide ongoing support for regulatory issues and changes to existing products, maintain and improve digital health regulatory SOPs, negotiate with regulatory agencies
Seniority
Mid-Senior, hands-on IC