Manager, Field Action Process
Core
Manage Cepheid's global Field Action process to ensure compliant execution of recalls, corrections, removals, and post-market actions for medical devices and diagnostics.
Role type
Senior Manager, Post-Market Quality
Builds
Global field action execution and regulatory compliance for medical device/diagnostic products
Domain
Medical Devices / In Vitro Diagnostics / Regulatory Quality
Required skills
Field action management, regulatory compliance (FDA/ISO), team leadership, process improvement, audit readiness, documentation review, stakeholder coordination
Preferred skills
Global field action leadership, regulatory inspection experience, Danaher Business System, quality certifications (RAC/CQE/CQA)
Technologies
FDA 21 CFR Part 7/806, ISO 13485, EU IVDR/MDR, Danaher Business System tools
Responsibilities
Manage daily execution of global Field Action process including initiation, assessment, and closure; Ensure standard work adherence and documentation quality; Provide regulatory oversight for field action decisions; Lead daily management routines and metric reviews; Review and approve field action documentation; Identify process gaps and drive continuous improvement; Support regulatory inspections and audits
Seniority
Senior Manager, hands-on leadership