Senior Manager, Combination Products & Medical Devices
Core
Lead global cross-functional quality system processes and design control activities to ensure compliance of combination products and medical devices with worldwide regulations.
Role type
Senior Manager, Quality Assurance (Medical Devices & Combination Products)
Builds
Compliant combination products and medical devices for global markets
Domain
Life Sciences / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality System requirements, Design control, Risk management, Supplier management, Regulatory compliance (combination products & medical devices), Cross-functional leadership, Audit preparation, Change control analysis
Preferred skills
Advanced degree, Combination product experience, 3rd party supplier management experience
Technologies
GMP QA, Risk management methodologies
Responsibilities
Manage interrelated function activities related to design control with R&D and Operations; Lead complex global cross-functional quality system process improvement teams; Perform 3rd party supplier management activities including review, approval, and site visits; Support preparation of regulatory inspections and internal audits; Mentor product team members through the design process.
Seniority
Senior, hands-on IC with leadership responsibilities