Post Market Surveillance Manager

Job Description

Agilent is currently seeking an experienced Quality Leader to join the Diagnostics and Genomics Group (DGG) team. Within DGG, we serve our customers who are deeply involved in improving human health. Whether it is to fight cancer or to improve the quality of life for those with a genetic disorder, patients are benefiting from the trusted answers our products deliver. Every day this role, you are making a difference in someone's life.

Position Overview

This management role (with direct reports) will provide leadership to ensure compliance is maintained for the Post-Market Surveillance activities required per In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746.

Principle Duties / Responsibilities

• Act as process owner for Post-Market Surveillance process including maintaining, monitoring, and continuously improving the process.
• Manage the team responsible for creation and update of Post-Market Surveillance Plans (PMSP), Post-Market Performance Follow-up Plans (PMPFP), Post Market Surveillance Reports (PMSR), Periodic Safety Update Reports (PSUR), and Post Market Performance Follow-up Report (PMPFR) with information from the Quality Management System (QMS) and facilitate analysis of the data by a cross-functional team (Quality, R&D, Regulatory Affairs, and Manufacturing).
• Ensure that reporting of PMSR / PSUR / PMPFR to the applicable Notified Body is performed in a timely, consistent, and compliant manner.
• Ensure the post market surveillance process is carefully aligned with the risk management and performance evaluation processes.
• Develop a process for evaluation of complaint trends to determine if action is required.
• Coordinate required updates to product documentation as a result of the post market surveillance review activities.

Qualifications

• Bachelor or Master's degree in Engineering or Scientific/Technical discipline
• Minimum of 7 years professional experience in Quality in the medical device industry
• Minimum of 7 years supervisory experience (managing direct reports), including hiring, training, coaching and performance management activities
• Direct experience in post market surveillance processes under MDR or IVDR (preferred)
• Strong knowledge and understanding of standards and regulations: ISO 14971:2019, Regulation (EU) 2017/746, FDA CFR 21 Part 820, ISO 13485
• Strong analytical skills with focus on finding the right solutions in compliance with the regulations.

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The US pay range for this full-time position is $115,680.00 - $213,285.00/yr, 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: https://careers.agilent.com/locations/americas/united-states

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 [email protected] or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required

Occasional

Schedule

Schedule:Full time

Shift

Day

Duration

No End Date

Job Function

Quality/Regulatory