Description
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.
Qualifications
Bachelor's or Masters of Science degree in Engineering or Scientific/Technical discipline.
Minimum of 8 years relevant professional experience in the MD/IVD, Pharma, or other related Life Science industry.
Minimum of 8 years working with remedial actions, such as Field Actions, Field Safety Notices (FSN) or Field Safety Corrective Actions
Must have excellent professional writing skills.
Prior experience with and knowledge of FDA, EU MDR, and Canada field action regulations and execution processes.
The US pay range for this full-time position is $103, - $169,, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position across the relevant US locations. 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. Additional details are available at:
Agilent 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 or contact +1-262-754-5030.For more information about equal employment opportunity protections, please visit
Option to Work Remote
Yes
Travel Required
Occasional
Shift
Day
Duration
No End Date
Job Function
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