Regulatory Lead - Medical Device Software
Core
Own global regulatory strategy and lifecycle oversight for medical device software products, ensuring compliance and driving market access.
Role type
Senior Regulatory Lead (Medical Device Software)
Builds
Medical device software products for cancer care clinics globally
Domain
Medical Device Software / Oncology / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, EU MDR compliance, Technical documentation, Design control processes, IEC 62304, IEC 60601, ISO 14971, Project management, Stakeholder management
Preferred skills
FDA submissions (eSTAR/510(k)), IEC 62366, ISO 14155, Cybersecurity requirements, AI/ML-enabled medical devices
Technologies
None explicitly listed as tools/frameworks
Responsibilities
Drive global regulatory strategy for product lifecycle, Lead preparation and review of Technical Documentation and regulatory submissions, Act as regulatory expert in development projects, Coordinate multiple projects and submission timelines, Partner with Development, Strategy, and Sales teams, Support inspections, audits, and post-market activities
Seniority
Senior, hands-on IC