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Pre and Post Market Risk Expert - Molecular

bioMerieux

bioMerieux

Salt Lake City, UT, USA · Utah, USA · United States
Posted on Jan 14, 2025
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Pre and Post Market Risk Expert - Molecular

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

A world leader in the field of in vitro diagnostics for more than 60 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 6,200 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.

Description

Reports directly to the VP of Pre & Post Market Quality – Molecular. The primary purpose of role is to oversee and manage the product risk management processes within the franchise, ensuring compliance with procedure, and therefore regulatory standards and enhancing the safety and effectiveness of IVD and non-IVD products.

The overall objective of the role is to adopt a product risk management framework within the franchises that aligns with the company’s quality management system. This role provides guidance and expertise within a portfolio (and in some cases across portfolios), as subject matter expert regarding Risk Management, Quality Standards, Product Development Risk Process, Product Manufacturing Risks and Controls, and any other Product/System Life Cycle initiatives involving Risk Management.

Primary Duties:
  1. Perform all work in compliance with company quality procedures and standards.
  2. Participates in and/or supports the development of R&D Quality Risk Plan(s).
  3. Serves as member of a Core Team or Project team as Global Quality Risk representative.
  4. Owns training modules and performs training for Risk Analysis (Product/Process).
  5. Updates / Approves the product and process risk analyses all along the Product/System Life Cycle
  6. Ensure compliance of assigned products to Product Risk Management internal Processes, and doing so to Standards and Regulations
  7. Stay informed of global regulations related to risk management.
  8. Develop and establish principles of Harmonization and standardization within and across franchises about Product Risk Management Activities with Global Quality Risk BPO.
  9. Guarantee the consistency of the global systems approach and consistency of decisions between the different Life Cycle Management phases
  10. Establish methods to facilitate Risk Based approach in the interest of patients, users, consumers across Product Life Cycle Management
  11. Complete graphs and/or presentations for regular quality updates.
  12. Support an environment of continuous improvement throughout the organization.
  13. Manage improvement project.
  14. Act as a subject matter expert during regulatory inspections and audits, as needed.
  15. Performs other duties as assigned.

Supplemental Data:

  • Ability to work well within a cross-functional team environment.
  • Capable to complete work in a time-sensitive environment
  • Able to begin, lead and oversee complex projects independently.

Training and Education:

Bachelors in related scientific field (e.g. biology, chemistry, bioengineering) and minimum 7 years, or Masters with minimum 6 years experience, or PhD with minimum 4 years experience

Experience:

  1. 7+ years in regulatory affairs, R&D or equivalent regulated industry employment position, medical device/IVD industry preferred
  2. 4+ years leading projects

Knowledge, Skills, Abilities:

Familiar with ISO standards, regulatory requirements (CE/FDA/ QSR).
Ability to think strategically, identify and mitigate regulatory risks and maintain regulatory compliant processes and procedures.
Must demonstrate strong leadership skills.
Personable and service oriented with attention to detail, excellent organizational and time management skills.
Excellent written and verbal communication skills.
Comprehensive knowledge of regulations applicable to medical device/IVD industry. Must be able to interpret regulatory requirements, determine needs for maintaining compliance, and effectively communicate this information to stakeholders.
Ability to influence peers, higher leaders and external expert or regulatory bodies.

The ability to work closely with management to identify and communicate areas of technical and timeline risks.

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Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com.

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 recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).

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