Senior Manager, Software Device Quality
Core
Senior leader ensuring compliance with quality and regulatory requirements for software medical devices and combination products across the full lifecycle.
Role type
Senior Manager, Software Device Quality
Builds
Software medical devices and combination products
Domain
Medical Devices / Regulatory Quality
Deliverable
client delivery
Required skills
Risk management, Design controls, Regulatory submissions, Change control, Verification and validation, Root cause analysis, Document control, Audit leadership
Preferred skills
Auditor certification, Pharmaceutical or biotech industry experience, Software medical device background
Technologies
ISO 13485, MDSAP, ISO 14971, MDR, 21 CFR Part 820
Responsibilities
Partner with product development to lead quality activities including risk management and design verification; Provide quality oversight for change control and design updates; Maintain Design History Files and Technical Files; Support global regulatory submissions and approvals; Oversee verification and validation activities; Own and maintain risk management files; Lead or support regulatory inspections and audits; Provide quality support for complaints, CAPA, and vigilance reporting; Drive inspection readiness and continuous improvement initiatives.
Seniority
Senior Manager, strategic leadership & cross-functional oversight
