Staff Quality Compliance Engineer
Core
Lead global regulatory compliance and standards management for medical device products across the product lifecycle.
Role type
Staff Quality Compliance Engineer (Regulatory & Standards)
Builds
Compliance action plans, regulatory alignment strategies, and audit-ready documentation for medical devices.
Domain
Medical Devices / Healthcare / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory impact assessment, standards gap analysis, design controls, risk management, quality management systems (QMS), global medical device regulations, international standards interpretation
Preferred skills
Internal and external regulatory or quality audit support
Technologies
None stated
Responsibilities
Lead the Standards & Regulations Management Compliance program as Division Process Owner; Monitor and identify new or revised global regulatory requirements; Interpret regulatory requirements and provide guidance to product development and quality teams; Conduct gap assessments comparing regulations to existing processes; Evaluate impact of regulatory changes on commercialized products; Develop and implement compliance action plans; Support internal and external audits as a subject matter expert
Seniority
Staff, technical leadership & cross-functional partnership