Manager, Field Action Process

Danaher•Sunnyvale, CA

69d•Onsite

About The Position

The Manager, Field Action Process is responsible for managing Cepheid’s global Field Action process and ensuring consistent, compliant execution of field actions, recalls, corrections, removals, field safety corrective actions, customer notifications, and related post-market actions. Directly manages professional associates responsible for field action execution, including workload prioritization, coaching, performance feedback, development, and resource planning. This role provides day-to-day leadership for process execution, standard work adherence, record quality, regulatory alignment, and inspection readiness. The Manager will drive disciplined daily management, timely escalation, continuous improvement, and cross-functional coordination to ensure field action activities are executed in accordance with applicable FDA, ISO 13485, EU IVDR/MDR, and other global regulatory expectations.

Requirements

Bachelor’s degree in Science, Engineering, Quality, Regulatory Affairs, Life Sciences, or related discipline with 9+ years of relevant experience; OR Master’s degree with 7+ years of relevant experience.
Experience managing people, processes, or cross-functional programs within the medical device, in vitro diagnostic, biotechnology, pharmaceutical, or similarly regulated industry.
Demonstrated knowledge of field actions, recalls, corrections and removals, complaint handling, adverse event reporting, regulatory reporting, customer communications, and post-market quality system processes.
Working knowledge of FDA recall and correction/removal expectations, including 21 CFR Part 7 and 21 CFR Part 806, as well as ISO 13485, risk management principles, and global field action reporting expectations.
Experience implementing or sustaining standard work, daily management, process metrics, dashboards, escalation routines, audit readiness reviews, and continuous improvement activities in a regulated quality system.
Ability to identify documentation gaps, reconcile objective evidence across multiple records, clarify process ownership, and ensure records support traceable, inspection-ready conclusions.
Strong communication, coaching, prioritization, and stakeholder-management skills, with the ability to lead through ambiguity, drive timely decisions, and escalate compliance risks appropriately.

Nice To Haves

Direct management of global field actions, recalls, corrections and removals, or field safety corrective actions for in vitro diagnostic or medical device products.
Experience leading teams through regulatory inspections, notified body audits, internal audits, CAPA execution, or remediation of field action process findings.
Experience using Danaher Business System tools, daily management, visual management, standard work, kaizen, problem solving, and process-improvement methods to improve quality system performance.
Regulatory Affairs Certification (RAC), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Lean certification, or similar professional certification.

Responsibilities

Manage daily execution of the global Field Action process, including initiation, assessment, Field Action Board inputs, regulatory strategy, customer communication, distributor coordination, effectiveness checks, reconciliation, and closure readiness.
Ensure field action standard work is consistently followed across records, owners, regions, and functional partners, with clear expectations for documentation quality, traceability, objective evidence, and timely completion of required process steps.
Provide regulatory and quality oversight for field action decisions and documentation to support alignment with FDA recall expectations, 21 CFR Part 7, 21 CFR Part 806, ISO 13485, EU IVDR/MDR, Health Canada, and other applicable global requirements.
Lead daily management routines, action tracking, aging reviews, issue escalation, and metric reviews to maintain process control and prevent delays.
Review and approve field action documentation, including Field Action Reports, reportability assessments, regulatory submissions, Field Safety Notices, distribution lists, effectiveness check plans, response reconciliations, and closure packages.
Identify recurring process gaps, documentation inconsistencies, audit findings, training needs, and execution risks, and translate them into corrective actions, standard work improvements, governance enhancements, and measurable process improvements.
Support regulatory inspections, notified body audits, internal audits, and management reviews by maintaining audit-ready field action records, defensible rationale, objective evidence, and clear process performance metrics.