Senior Field Actions Specalist
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
Benefits
- paid time off
- medical/dental/vision insurance
- 401(k)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
