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Postmarket Surveillance Specialist III

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

Description

Come be a part of our team and our mission

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.

The Postmarket Surveillance Specialist III (PSS-III) is responsible to conduct, review, and close complaint investigations. This position will work with management in enhancing the complaint investigation closure time and process. The PSS-III supports and helps in troubleshooting the product, identifies trends, and problem areas as they arise. The PSS-III will support Postmarket management in improving internal processes KPI’s, literature review process, and product trending and performance in the field. 

Essential Job Duties and Responsibilities

  1. Perform all work in compliance with company policy and within the guidelines of BioFire’s Quality System.
  2. Follows laws and regulations applicable to Postmarket Surveillance.
  3. Conducts, reviews and closes complaint investigations within the Complaint Investigation software tool according to processes.
  4. Conducts and reviews escalated complaints for potential reportable events.
  5. Coordinates with regulatory affairs to complete reportable event documentation.
  6. Review trend charts and perform data analysis.
  7. Work with experts from other departments during investigation process.
  8. Review complaints for CAPA.
  9. Conduct product literature review and work with other departments to address product performance in the field.
  10. Perform weekly statistical performance review to monitor manufactured product.
  11. Ensure trends are reported to the Postmarket surveillance management.
  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 Post Market Surveillance processes and work with management to identify problem areas and implement solutions.
  14. Coordinates input on data from other functional teams.
  15. Supports and performs level II job duties as needed.
  16. Performs other duties as assigned.

 

Supplemental Data

N/A

Qualifications

Training and Education

Bachelor’s degree in Scientific Field.  

 

Experience

  • 5 year of laboratory experience and troubleshooting molecular tests. Microbiology or clinical lab experience is preferable.
  • Film Array experience preferred

Knowledge, Skills and Abilities

  • Detail-oriented
  • Organizational skills
  • Data analysis
  • Effective writing and communication skills
  • Time management
  • Analytical skills
  • Ability to work independently
  • Ability to follow detailed processes
  • Strong knowledge of the clinical molecular diagnostic field’s concepts, practices, procedures, rules and regulations.
  • Knowledge of medical device regulation preferred

 

Physical Requirements

Physical requirements found in a typical office setting

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