Manager, Field Action Process

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At Cepheid one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

At Cepheid we are passionate about improving health care through fast accurate molecular diagnostic systems and tests. As a member of our team youll get to make an immediate measurable impact on a global scale within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the worlds most complex health challenges. Together we bring MORE change to the world.

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The Manager Field Action Process is responsible for managing Cepheids 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.

This position reports to the Director Adverse Events and Field Actions and is part of the Post Market Quality Organization located in Sunnyvale CA and will be an on-site role.

In this role you will have the opportunity to:

• 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.

The essential requirements of the job include:

• Bachelors degree in Science Engineering Quality Regulatory Affairs Life Sciences or related discipline with 9 years of relevant experience; OR Masters 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.

It would be a plus if you also possess previous experience in:

• 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.

The annual salary range for this role is $. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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