Senior Field Actions Specialist
Danaher Corporation
Summary
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.
Job description
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.
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.
Benefits
- Health care program
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Bonus/incentive pay
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.