Manager/Sr Manager, Postmarket Surveillance

Description

The Postmarket Surveillance (Senior) Manager, under the supervision of a Postmarket Surveillance director, is responsible for developing the strategic direction and implementing the processes related to compliant investigations completion, trending, and monitoring. Performing and assisting in all of the Postmarket Surveillance Specialist II and III duties and responsibilities as well as assess with onboarding, training, assigning and reviewing work performance, and assess with annual work performance appraisals and discipline. Provide guidance to various cross functional team on clinical workflow and how products are used to identify potentially hazardous situations. Review escalated complaint for medical device reporting or field corrective action and work with the regulated product and clinical affair director to complete these reviews according to proper documentation.

Essential Job Duties and Responsibilities

1. Perform all work in compliance with company policy and within the guidelines of BioFire’s Quality System.
2. Oversee escalated complaint processing in compliance with applicable regulations and standards such as FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, MDSAP, In Vitro Diagnostics Regulation, etc.
3. Provide clinical expertise to the complaint handling unit to assist in proper evaluation of customer complaints.
4. Coordinates with regulatory affairs to complete reportable event documentation.
5. Implement recall activities and work with corporate regulatory affairs and quality assurance management to asses’ recall-related events.
6. Review trend charts and perform data analysis.
7. Monitor departmental key performance indicators (KPIs) and analyze for opportunities to optimize performance.
8. Directly supervises staff, which includes interviewing, hiring, orienting, onboarding, training, assigning and reviewing work performance, annual work performance appraisals and discipline.
9. Responsible for timesheet approval, PTO approvals and attendance tracking. Work with experts from other departments during investigation process.
10. Review complaints for CAPA.
11. Conduct product literature review and work with other departments to address product performance in the field.
12. Uses wide-ranging experience, detailed information gathering, analysis, and investigation to resolve complex issues in innovative and effective ways.
13. Maintains broad knowledge of state-of-the-art principles and theories, and conducts benchmarking across industry to continually keep up with best-in-practice processes.
14. Ensure PSS I & II are adequately trained and prepared to handle complaints associated with new products before they are released for distribution to the field.
15. Assess in the development and improvements of the current Postmarket Surveillance processes and work with management to identify key milestones and help develop realistic project plans and solutions.
16. Supports and performs level III job duties as needed.
17. Collaborate with bioMerieux's leadership team for planning, execution, and oversight of the post-market surveillance program and continuous process improvement.
18. Performs other duties as assigned. 

Qualifications

Manager

Training and Education

Bachelors’ in Scientific field required Masters degree preferred..  

Experience

• Minimum six years’ experience with clinical diagnostic testing; previous experience with molecular or microbiological diagnostics preferred.
• Minimum three years’ experience with quality systems with knowledge and understanding of the PMS requirements reflected in ISO 13485.

Senior Manager

Training and Education

Ph.D. or Master’s degree (with significant training/experience) in a relevant scientific field.  

Experience

• 3 years of experience in the IVD industry preferably in combination with Postmarket Surveillance, Product Lifecycle and related processes.

Manager/Sr Manager

Knowledge, Skills and Abilities

• Clear and concise writing and communication skills.
• Organized and able to manage multiple projects simultaneously.
• The ability to work cross-functionally to complete a task on time.
• Advanced technical and analytical skills related to molecular diagnostics and scientific data interpretation/experimental design.
• The ability to work closely with Director of Postmarket Surveillance to identify and communicate areas of technical, schedule, and budget risk.
• Self, motivated, strong attention to detail, excellent organizational skills and time management abilities are essential.
• Knowledge of molecular biology (including real-time PCR), microbiology, clinical laboratory testing, product development and/or regulatory submissions.