Global Regulatory Affairs and Compliance Manager
Core
Lead assigned Quality System processes, internal audits, customer audits, ISO Registration audits, and FDA Inspections for medical device regulations.
Role type
Senior IC Regulatory Affairs and Compliance Manager
Builds
Quality System processes and compliance programs for medical device business units
Domain
Medical Devices / Quality Systems
Required skills
Medical device regulations (21 CFR 820, ISO 13485), Quality System development, Internal and external audit leadership, FDA submission management, Risk management, Change control, Supplier audit management, Business continuity planning, Validation writing, Metrics reporting
Preferred skills
Lean or Six Sigma, Program change management, RAPS Certification
Technologies
Word, Excel, PowerPoint
Responsibilities
Lead assigned Quality System processes including internal, customer, ISO, and FDA audits; Serve as primary contact for site departments and corporate functions; Ensure site compliance with medical device regulations and standards; Lead department activities in Document Control, Training, CAPA, Change Control, and Auditing; Lead follow-up and resolution of issues with regulatory agencies; Develop and enhance regulatory knowledge; Support currently marketed products including review of engineering changes and labeling; Propose and execute Quality System improvement opportunities; Establish and report Quality System metrics; Manage expenses and support budget planning
Seniority
Senior, hands-on IC with team management