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Postmarket Surveillance Specialist I or II

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

Description

BioFire Diagnostics, LLC. is looking for an experienced Postmarket Surveillance Specialist to join our growing team!

This position will review, investigate, triage and close escalated compliant investigations to conclude if a medical device malfunction has occurred. This position requires understanding of laws and regulations for compliance within the scope of the department (21CFR 820.198 and 21 CFR 211) (ISO 13845 and MDSAP). As needed, the Postmarket Surveillance Specialist (PSS) will coordinate investigations with departmental teams to identify root cause of an escalated complaint. Timeliness of this work is expected, as the turnaround time for investigations is critical. As the complaint investigation reports are routinely reviewed by external auditors, knowledge of the subject matter and attention to detail are expected. As part of the team the PSS will also be responsible to monitor and track escalated complaints, suggestions and ensure that trends are investigated and reported to management. 

Principal Job Duties and Responsibilities:

  1. Conduct investigation on elevated FilmArray complaints within the Complaint Investigation.
  2. Determine probable cause by assessing run files, evidence gathered from the customer, manufacturing records and associated complaints.
  3. Work with customer support to advise an RMA, product replacement or appropriate re-training.
  4. Investigate the potential for malfunction impact on patient care.
  5. Triage additional investigation to departments when needed.
  6. Report timeliness of complaint investigation turnaround.
  7. Analyze complaint data for trends to alert to management and suggest follow up actions.
  8. Maintain awareness of changes to the global regulatory requirements within the department scope.
  9. Regularly coordinate with functional departments to monitor pouch, instrument, software, and field metrics to assess product performance over time.
  10. Review scientific literature for discrepancies and to determine of the products are being used as intended.
  11. Participate in both internal and external audits when required.
  12. Participate in department processes and workflow improvement activities.
  13. Assist in the development and review of corporate and department procedures.
  14. Perform other related duties as required.

Training and Education:
Level I

  • Bachelor’s degree in a scientific field related to Medical Technology, Microbiology or Molecular Biology, OR Associate’s degree and 2 years of related lab experience.


Level II

  • Bachelor’s degree in Scientific Field related to Medical Technology, Microbiology or Molecular Biology. Minimum 3 years experience troubleshooting of molecular or microbiological diagnostic test.

Experience:

  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
  • Knowledge of microbial identification methods.
  • Knowledge and experience with laboratory processes and procedures.
  • Experience troubleshooting hardware, software, and medical device reagents.
  • Experience coordinating cross-functional teams.
  • Demonstrate initiative and have the ability to work both independently and collaboratively in a team structure.

 Skills:

  • Molecular and Microbiological diagnostic product data assessment.
  • Strong attention to quality/detail.
  • Data analysis.
  • Strong interpersonal and communication skills (written and verbal).
  • Excellent organizational, time management and administrative skills.
  • Ability to handle multiple tasks and priorities.
  • Demonstrate initiative and have the ability to work both independently and collaboratively in a team structure.
  • Proficient with computer and standard software programs (Microsoft Office, Adobe Pro).
  • Analytical skills.

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