Regulatory Affairs Director
Core
Lead regulatory strategy and execution for Cardiovascular Diagnostics & Services and Patient Care Services in the Electrophysiology Therapies Operating Unit, managing global approvals, registrations, audits, and inspections.
Role type
Director-level Regulatory Affairs leader (IC with people management)
Builds
Regulatory submission packages, license renewals, annual registrations, and strategic compliance frameworks for medical devices.
Domain
Healthcare technology / Medical Devices / Cardiovascular Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device regulatory affairs, global regulatory submissions, audit and inspection management, labeling and marketing compliance, cross-functional stakeholder influence, strategic workforce planning, team leadership, process innovation
Preferred skills
Navigating complex regulatory environments, innovating regulatory strategies for new spaces, executive briefing, long-term alliance building
Technologies
Regulatory submission systems, compliance tracking tools
Responsibilities
Direct coordination of document packages for regulatory submissions, lead material compilation for license renewals and annual registrations, recommend changes for labeling and clinical protocols, monitor tracking and control systems, direct interaction with regulatory agencies, provide motivational and technical leadership to the team, manage performance and employee development
Seniority
Director, strategic leadership & people management