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Agilent Technologies
The Global Quality and Regulatory Affairs (GQRA) Field Action Specialist’s responsibilities include managing Field Action Activities such as: leading Field Action Strategy and Field Safety Communication meetings, recalls, field notifications and correction processes for medical and non-medical products. Duties include preparation of the required documentation of field action customer notification and acknowledgement letters, coordination of field notices, Health Hazard Evaluations, notices to Health Authorities and notified bodies, updates letters and status to Health Authorities and monitoring of regulatory termination requests.
Thie position includes monitoring of the escalated product quality issues, executing the Field Actions, and verification of their effectiveness until closure by:
Work with product investigation and CAPA teams in the collection of event information and documentation of investigations for presentation in decision-making meetings.
Run consignee list and work with Field Service teams to coordinate notifications and customer contacts
Verifying and checking investigation summaries and other quality documentation which will be subject to regulatory inspection.
Creating field action strategy, writing field (safety) notices, field action customer letters and coordinating the proper reviews with organization stakeholders.
Report field actions to global Health Authorities, notified bodies, and interface on a frequent basis with global in-country teams to execute the field actions.
Maintain and develop QMS processes and procedures for the Field Action processes, and continuously improve the process and the procedures.
Maintaining tracking of customer follow ups and acknowledgements ensuring inspection-ready documentation is clear and accurate
Communicate with the broader Agilent organization, as appropriate, about activities related to the Field Action position
Monitor and influence progress for status updates of Field Actions by holding meetings and/or following up with In-country contacts, documenting all attempts to receive information
This position works with global Health Authorities to inform them of the field actions, and to monitor and report status to the Health Authorities, and to request closure of the Field Actions
Excellent writing skills, as the position represents Agilent to various teams and global Health Authorities
Job Responsibilities:
Regular tasks
Evaluate escalation information regarding Field actions.
Assist business investigation teams with reviewing slide decks created for the Quality Regulatory Alignment Meetings (QRAM) and Field Action Committee meetings ensuring the product investigations are robust, and questions and follow ups are answered promptly
Escalate product quality issues where necessary from data gathered in post market team meetings regarding potential Field Actions.
Ensure notified bodies (ie, TUV, UL or others) are notified of the Field Action decisions
Provide information and metrics for Field Actions, including Executive Management Reviews, business Management Reviews (MRs) and other product review meetings.
Continuous awareness of new regulation and guidelines within IVD and recommending changes to ensure compliance.
Routinely analyzing and evaluating systems and processes to improve work processes and service to internal customers
Participating in planning, execution and follow up on internal and external quality audits.
Ad-hoc tasks related to the Field Action process
Project related tasks
Support of Field Actions investigations
Participate and lead cross-functional projects for the FA related issues.
Data collection/extract and analysis related to product corrections such as CAPAs, NCRs, and SCARs related to the Field Actions
Bachelor of Science degree in Engineering or Scientific/Technical discipline or other relevant education Master’s degree in
Minimum of 2 years relevant professional experience in the MD/IVD, Pharma, or other related Life Science industry.
Minimum of 2 years working with remedial actions, such as Field Actions, Field Safety Notices (FSN) or Field Safety Corrective Actions Must have excellent professional writing skills in English
Prior experience with and knowledge of FDA, EU MDR, and Canada field action regulations and execution processes
