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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Additional Details
This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least November 6, 2024 or until the job is no longer posted.The full-time equivalent pay range for this position is $121,600.00 - $224,200.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.
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