Pre and Post Market Risk Expert - Molecular
Company: bioMerieux Inc.
Location: Salt Lake City
Posted on: January 26, 2025
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Job Description:
Pre and Post Market Risk Expert - Molecular
Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Quality
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A world leader in the field of in vitro diagnostics for more than
60 years, bioMerieux 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:Perform
all work in compliance with company quality procedures and
standards. Participates in and/or supports the development of
R&D Quality Risk Plan(s). Serves as member of a Core Team or
Project team as Global Quality Risk representative. Owns training
modules and performs training for Risk Analysis (Product/Process).
Updates / Approves the product and process risk analyses all along
the Product/System Life Cycle Ensure compliance of assigned
products to Product Risk Management internal Processes, and doing
so to Standards and Regulations Stay informed of global regulations
related to risk management. Develop and establish principles of
Harmonization and standardization within and across franchises
about Product Risk Management Activities with Global Quality Risk
BPO. Guarantee the consistency of the global systems approach and
consistency of decisions between the different Life Cycle
Management phases Establish methods to facilitate Risk Based
approach in the interest of patients, users, consumers across
Product Life Cycle Management Complete graphs and/or presentations
for regular quality updates. Support an environment of continuous
improvement throughout the organization. Manage improvement
project. Act as a subject matter expert during regulatory
inspections and audits, as needed. Performs other duties as
assigned. Supplemental Data:
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 bioMerieux 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 or contact us at .
BioMerieux 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
BioMerieux'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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Keywords: bioMerieux Inc., Ogden , Pre and Post Market Risk Expert - Molecular, Other , Salt Lake City, Utah
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