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Agilent Technologies · 9 hours ago

Field Action Specialist

Sacramento, CA

Full-time

Hybrid

Senior Level, Lead/Staff

$88K/yr - $164K/yr

8+ years exp

Agilent Technologies is seeking a Field Action Specialist to manage Field Action Activities for medical and non-medical products. This role involves developing strategies, managing recalls, and ensuring compliance with regulatory requirements while collaborating with various teams to address product quality issues.

BiotechnologyHealth CareHealth DiagnosticsLife SciencePharmaceutical

Culture & Values

Responsibilities

Collaborate with product investigation and CAPA teams to gather event information and document investigations for presentation in decision-making meetings

Generate consignee lists and coordinate notifications and customer contacts with Field Service teams

Review and verify investigation summaries and quality documentation to ensure compliance and readiness for regulatory inspections

Develop field action strategies, draft safety notices and customer letters, and manage stakeholder reviews for accuracy and alignment

Report field actions to global Health Authorities and notified bodies, and work closely with in-country teams to ensure timely execution

Maintain and enhance QMS processes and procedures related to Field Actions, driving continuous improvement

Track customer follow-ups and acknowledgements, ensuring documentation is clear, accurate, and inspection-ready

Communicate updates across the broader Agilent organization regarding Field Action activities

Monitor and influence progress on Field Action status updates by hosting meetings and following up with in-country contacts, documenting all efforts

Engage with global Health Authorities to inform them of actions, provide status updates, and request closure of Field Actions

Demonstrate excellent writing and communication skills, representing Agilent professionally to internal teams and global regulatory bodies

Evaluate escalation data related to potential Field Actions and determine appropriate next steps

Support business investigation teams by reviewing presentation materials, ensuring investigations are thorough, and follow-up actions are addressed promptly

Collect, extract, and analyze data related to product corrections, including CAPAs, NCRs, and SCARs associated with Field Actions

Notify relevant bodies (e.g., TUV, UL, or others) of Field Action decisions in compliance with regulatory requirements

Provide metrics and reporting for Field Actions to support Executive Management Reviews, business Management Reviews (MRs), and other product review meetings

Stay current on evolving regulations and guidelines within the IVD space and recommend changes to maintain compliance

Analyze and evaluate systems and processes regularly to identify opportunities for improvement and enhance service to internal stakeholders

Participate in internal and external quality audits, including planning, execution, and follow-up activities

Support Field Action investigations, ensuring timely and accurate data collection and documentation

Lead and participate in cross-functional projects addressing Field Action-related issues and driving resolution

Qualification

Field Action ManagementRegulatory ComplianceProfessional WritingMedical Device ExperienceVitro Diagnostics KnowledgeFDA RegulationsEU MDR KnowledgeData AnalysisCommunication SkillsTeam Collaboration

Required

Bachelor's or master's degree in engineering or a Scientific/Technical discipline

Minimum 8 years of relevant professional experience in the Medical Device (MD), In Vitro Diagnostics (IVD), Pharmaceutical, or related Life Science industry

Minimum 8 years of experience managing remedial actions, including Field Actions, Field Safety Notices (FSN), or Field Safety Corrective Actions

Exceptional professional writing skills in English, with the ability to communicate clearly and effectively with global regulatory authorities and internal stakeholders

Strong knowledge and prior experience with FDA, EU MDR, and Health Canada field action regulations and execution processes