Global Regulatory Affairs and Compliance Manager
Core
Lead Quality System processes, internal and external audits (FDA, ISO), and regulatory submissions for medical device compliance.
Role type
Senior IC Regulatory Affairs and Compliance Manager
Builds
Compliant medical device quality systems and regulatory submissions
Domain
Medical Devices / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device regulations (21 CFR 820, ISO 13485), Quality System management, Audit leadership, Risk management, Change control, Supplier audit management, Validation writing, Budget management
Preferred skills
Lean or Six Sigma, Program change management, RAPS certification
Technologies
Word, Excel, PowerPoint
Responsibilities
Lead assigned Quality System processes and internal/external audits; Ensure site compliance with medical device regulations; Lead department activities in Document Control, CAPA, and Risk Management; Negotiate and resolve issues with regulatory agencies; Support currently marketed products including engineering changes and labeling; Establish and report Quality System metrics; Manage expenses and budget planning.
Seniority
Senior, hands-on IC with team management
