Regulatory Affairs Manager – Heart Failure (on-site)
Core
Manage regulatory submissions and strategy for heart failure medical devices to ensure compliance with US and international legislation.
Role type
Manager, Regulatory Affairs (Medical Devices)
Builds
Regulatory submissions (510(k), PMA, IDE) for heart failure devices
Domain
Healthcare / Medical Devices / Regulatory Compliance
Required skills
Regulatory submission management, risk assessment, cross-functional leadership, strategic planning, technical writing, stakeholder negotiation
Preferred skills
Supervisory experience, EU MDR knowledge, medical device software regulations, RAC certification
Technologies
510(k), IDE, PMA, EU MDR
Responsibilities
Lead functional groups to complete regulatory submissions, anticipate regulatory obstacles, interpret and apply domestic and international regulations, negotiate with regulatory agencies, define regulatory strategy, manage complex projects
Seniority
Manager, individual contributor with department influence