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Postmarket Surveillance Manager

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

At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.

We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.

BioFire Diagnostics, LLC. is looking to add a Postmarket Surveillance Manager to our growing team!  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 complaints for medical device reporting or field corrective action and work with the regulated product and clinical affairs 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 the 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 assess recall-related events.

6.     Review trend charts and perform data analysis.

7.     Monitor departmental key performance indicators (KPIs) and analyze 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 the 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 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.

Minimum Qualifications

Training and Education: Bachelors’ in Scientific field required Master's degree preferred.

Experience: 

  • Minimum six years’ experience with clinical diagnostic testing; previous experience with molecular or microbiological diagnostics preferred.
  • Minimum of 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

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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