Senior Field Actions Specialist

Location: Sunnyvale, California, United States; on-site role

Annual salary: $103,500–$142,500, plus eligible bonus or incentive pay

Company

Life sciences and diagnostics organization developing molecular diagnostic systems and tests for complex health challenges.

What you will do

• Execute global field action compliance activities, including recalls, corrections, removals, field safety corrective actions, customer notifications, monitoring, effectiveness verification, and closure.
• Provide regulatory compliance guidance to the Field Action Board and cross-functional stakeholders on reportability, risk assessment, execution strategies, and regulatory obligations.
• Author, review, and approve Field Action Reports, reportability assessments, health hazard evaluations, regulatory submissions, customer communications, and closure records.
• Drive harmonization and continuous improvement of field action procedures, governance processes, metrics, dashboards, and monitoring tools.
• Lead inspection-readiness activities and support regulatory inspections, notified body audits, and health authority interactions.

Requirements

• Bachelor’s degree in science, engineering, quality, regulatory affairs, life sciences, or a related discipline with 5+ years of relevant experience; or a master’s degree with 3+ years; or a doctoral degree with 0–2 years.
• Experience in the medical device, in vitro diagnostic, biotechnology, pharmaceutical, or another regulated industry.
• 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 inspections, external audits, or health authority interactions.
• Must work on-site in Sunnyvale, California, United States.

Nice to have

• Global field action management experience for in vitro diagnostic or medical device products.
• RAC, CQE, CQA, or similar professional certification.
• Experience leading enterprise quality-system, compliance, or process-improvement initiatives.

Culture & Benefits

• Culture focused on belonging, continuous improvement, innovation, and measurable impact.
• Comprehensive benefits including paid time off and medical, dental, and vision insurance.
• 401(k) benefits for eligible employees.
• Opportunities to contribute to enterprise-wide projects and collaborate with global cross-functional teams.