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Manager, Postmarket Surveillance Scientist

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

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Description

The Postmarket Surveillance Scientist, under the supervision of a Postmarket Surveillance associate director, is responsible for developing the strategic direction and implementing the processes related to the postmarket surveillance requirement for the EU In Vitro Diagnostic Medical Device Regulation (IVDR) for bioMerieux's in vitro diagnostic products. Oversees activities tied to postmarket regulatory requirements including writing reports to support EU regulatory submissions and annual product-specific postmarket surveillance reports. Develops, executes, and reviews processes/reports for country specific postmarket surveillance regulatory requirements (i.e. China, Canada, Saudi Arabia, etc.). Supervises a team of Postmarket Surveillance Specialists and  oversees the review, investigation, triage and closure of escalated compliant investigations. Includes reviewing escalated complaint for medical device reporting or field corrective action and work with the Regulatory Affairs team complete these reviews according to SOP.  

Essential Job Duties and Responsibilities: 
  • Perform all work in compliance with company policy and within the guidelines of the company's Quality System.
  • Contributes to the implementation and execution of In Vitro Diagnostic Medical Device Regulation (IVDR) activities with regards to Postmarket Surveillance.
  • Draft, review and update postmarket regulatory documents (e.g. Postmarket Performance Follow-up, Postmarket Safety Update Reports, Panel Risk Reports, etc.)
  • Work with a broad range of internal cross-functional groups including Manufacturing, R&D, Customer Support, Regulatory Affairs, Product Management, Marketing, Medical Affairs, and other stakeholders to complete necessary documents for IVDR.
  • Efficiently incorporate postmarket data into continual assessment of benefit-risk ratio for products, assessment of the safety and effectiveness of products, as well as the continual improvement of customer experience and usability.
  • Manage and train a team to support drafting of postmarket regulatory documents and any additional supporting postmarket activities.
  • Directly supervises staff, which includes hiring, orienting, onboarding, training, assigning and reviewing work performance, annual work performance appraisals, and discipline.
  • Support escalated complaint processing in compliance with applicable regulations and standards such as FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, MDSAP, EU In Vitro Diagnostics Regulation, etc.
  • Aid in the review of escalated complaint records and associated quality records (e.g. investigations, CAPA, NCRs).
  • Develop procedures for extracting real-world evidence from postmarket data for supporting potential future product claim expansions.
  • Uses wide-ranging experience, detailed information gathering, analysis, and investigation to resolve complex issues in innovative and effective ways.
  • Act as a representative to US FDA, global health authorities, and notified bodies during audits.
  • 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.
  • Define, develop, and implement short-term and long-term strategies, goals, objectives, and tactics relating to regulatory requirements for postmarket surveillance.
  • Collaborate with bioMerieux's leadership team for planning, execution, and oversight of the post-market surveillance program and continuous process improvement.
  • Performs other duties as assigned.
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.

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.

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. 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 BioMérieux’s or its affiliates’ 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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