Senior Global Field Action Compliance Lead

Cepheid; Sunnyvale (CA); Sur place; USD 104 000 - 143 000; Plein temps

Résumé du poste

Cepheid in Sunnyvale, CA, seeks a Senior Field Actions Specialist to lead global field action compliance within post-market quality. You will oversee recalls, removals, and customer notifications, ensuring alignment with FDA QMS and ISO 13485 requirements.

This on-site role reports to the Director of Adverse Events and Field Actions and offers cross-functional collaboration, enterprise-wide impact, and a path for career growth within a Danaher operating company.

Qualifications

• 5+ years in regulated medical device or diagnostics.
• Experience with FDA QMS and ISO 13485 knowledge.
• Experience authoring quality system documentation.
• Experience supporting regulatory inspections.

Responsabilités

• Execute global field action compliance activities including recalls and notifications.
• Advise FAB and stakeholders on reportability and obligations.
• Author and review Field Action Reports and regulatory submissions.
• Harmonize field action procedures, governance metrics and monitoring tools.
• Support inspections and health authority interactions for post-market activities.

Connaissances

Regulatory compliance

Post-market quality

Field actions management

Regulatory inspections

Documentation & reports

Formation

Bachelor's degree

Master's degree

Doctoral degree

Description du poste

Cepheid in Sunnyvale, CA, seeks a Senior Field Actions Specialist to lead global field action compliance within post-market quality. You will oversee recalls, removals, and customer notifications, ensuring alignment with FDA QMS and ISO 13485 requirements.

This on-site role reports to the Director of Adverse Events and Field Actions and offers cross-functional collaboration, enterprise-wide impact, and a path for career growth within a Danaher operating company.