The
Senior Field Actions Specialist is responsible for supporting Cepheid's global Field Action Compliance program and ensuring compliance with applicable worldwide regulatory requirements and Cepheid procedures associated with field actions, recalls, product notifications, market withdrawals, and other post-market actions. This role serves as a senior subject matter expert within Post Market Quality, providing compliance expertise, governance support, process harmonization, and continuous improvement contributions that have significant impact on patient safety, product quality, and business continuity. The position offers opportunities to contribute to enterprise-wide projects, partner with global cross-functional teams, and help advance Cepheid's post-market compliance framework.
This position reports to the Director, Adverse Events and Field Actions and is part of Post Market Quality Organization located in Sunnyvale, CA and will be an on-site role.
In this role, you will have the opportunity to:- Execute global field action compliance activities, including assessment, execution, monitoring, effectiveness verification, and closure of recalls, corrections, removals, field safety corrective actions, and customer notifications.
- Support strategic regulatory compliance guidance to the Field Action Board (FAB) and cross-functional stakeholders regarding reportability, risk assessments, execution strategies, and regulatory obligations.
- Author, review, and approve complex field action documentation, including Field Action Reports, reportability assessments, health hazard evaluations, regulatory submissions, customer communications, and closure records.
- Drive global harmonization and continuous improvement of field action procedures, governance processes, metrics, dashboards, and compliance monitoring tools.
- Lead field action inspection readiness activities and support regulatory inspections, notified body audits, and health authority interactions related to post-market compliance activities.
The essential requirements of the job include:- Bachelor's degree in Science, Engineering, Quality, Regulatory Affairs, Life Sciences, or related discipline with 5+ years of relevant experience; OR Master's degree with 3+ years of relevant experience; OR Doctoral degree with 0-2 years of relevant experience.
- Experience within the medical device, in vitro diagnostic, biotechnology, pharmaceutical, or similarly regulated industry.
- Demonstrated experience managing field actions, recalls, post-market quality activities, complaint handling, adverse event reporting, or regulatory compliance programs.
- Working knowledge of FDA Quality Management System Regulations, ISO 13485, risk management principles, and global field action reporting requirements.
- Experience authoring and reviewing regulated quality system documentation and supporting regulatory inspections, external audits, or health authority interactions.
It would be a plus if you also possess previous experience in:- Global field action management for in vitro diagnostic or medical device products.
- Regulatory Affairs Certification (RAC), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar professional certification.
- Leading enterprise quality system, compliance, or process-improvement initiatives.
Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The annual salary range for this role is
$103,500 - 142,500. 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 Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
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