Quality/Regulatory Manager - Field Actions

Ensures that quality products are designed and manufactured by Agilent, and are in alignment and compliance with national, regional and global regulations, company policies and business objectives.

Develops and implements programs and processes to ensure that Agilent products are safe, legal, and meet or exceed customer expectations for regulatory compliance.

Oversees and directs quality and/or regulatory activities and executes key strategic programs within assigned area of responsibility.

Acts as a change agent to help establish a customer-centered culture. Ensures quality management system (QMS) procedures are accurate and current.

Provides expertise in translating regulatory requirements into practical, workable plans.

Represents Agilent businesses with relationship to Field Action Activities, assessing business group impact, developing implementation strategies, and leading implementation; providing oversight of the execution of Product Recalls and Field Safety Corrective Action Notices with customers, distributors, and country or regional regulatory representatives; and communication with the FDA and other regulators regarding field actions, as needed.

Manages Field Action team operations for Field Action Strategy and Field Safety Communication meetings, recalls, field notifications and correction processes for medical and non-medical products. Oversees preparation of the required documentation of field action customer notification and acknowledgement letters, coordination of field notices, overseeing the development of Health Hazard Evaluations, notices to Health Authorities and notified bodies, updates letters and status' to Health Authorities and monitoring of regulatory updates and Field Action termination requests.

Providing oversight of the issue escalation and recall processes for business groups to assure Agilent addresses product quality issues that may result in a field action; Assuring standard processes and procedures exists across business groups. This position includes monitoring and submission of metrics for the Field Action process to business groups for Quality Management Reviews, scorecards, and other means of analyzing process performance.

Job Responsibilities:

• Leads and manages subordinate Individual Contributors, including daily operational activities, assignment of work, resource management, and issue resolution.

• Verifies and checks Field Action team deliverables, records, closure reports, and other quality documentation which will be subject to regulatory inspection.

• Oversight of field action strategy, writing field (safety) notices, field action customer letters and coordinating the proper reviews with organization stakeholders.

• Responsible for timely reporting of field actions to global Health Authorities, notified bodies, and may interface on a frequent basis with global in-country teams to execute the field actions.

• Continuously update and improve the procedures work instructions for Field Actions and related QMS processes

• 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

• Responsible for oversight of communications to 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

• Ensures 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 Quality Management Reviews (QMRs) 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.

• CAPA ownership, when necessary, for Field Action process improvements

• Ad-hoc tasks related to the Field Action and recall processes

Bachelor of Science degree in Engineering or Scientific/Technical discipline or other relevant education. Master's degree preferred or directly equivalent experience.

Minimum of 4 years relevant professional experience in the MD/IVD, Pharma, or other related Life Science industry.

Minimum of 2 - 4 years working with remedial actions, such as Field Actions, Field Safety Notices (FSN) or Field Safety Corrective Actions and other related post market surveillance activities

Must have excellent professional writing skills in English. At a minimum, prior experience with and knowledge of FDA, EU MDR, and Canada, and other global regulations

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