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Postmarket Surveillance Manager

Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Regulatory Affairs

Description

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

The Postmarket Surveillance Manager is responsible to manage the Postmarket related activities regarding review, and compliant investigations closure. 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. 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.
  13. 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.
  14. Supports and performs level III job duties as needed.
  15. Performs other duties as assigned.

 

Qualifications

Training and Education

Bachelors’ in Scientific field required Master 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.
  • FilmArray experience preferred.

Knowledge, Skills and Abilities

  • Advanced knowledge of applicable regulations and standards related to medical reporting in the USA and internationally.
  • Well-developed leadership skills, demonstrating a track-record of success in a high-growth environment
  • Demonstrated analytical skills combined with a solutions-oriented mentality
  • Thorough understanding of the clinical molecular diagnostic field’s concepts, practices, procedures, rules and regulations
  • Detail oriented
  • Organizational skills
  • Data analysis
  • Effective writing and communication skills
  • Time management
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