What are the responsibilities and job description for the Regulatory and Quality Compliance Expert position at bioMerieux Inc.?
Regulatory and Quality Compliance Expert
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 Director of Regulatory Affairs and Vigilance - Molecular. This position provides vigilance guidance, assesses regulatory risks throughout product lifecycle, maintains vigilance requirements, and disseminates regulatory compliance information. The role focuses on project ownership for field actions and / or adverse event reporting. The expert will be responsible for evaluation, preparation and implementation of field actions and / or vigilance reporting. The expert will be knowledgeable on all relevant procedures and regulations to make informed decisions regarding procedural updates and application of procedures.
Primary Duties :
- Perform all work in compliance with company quality procedures and standards.
- Assess reportability for both global and regional events; draft initial, follow-up, and final reports; and submit appropriate forms for adverse event reporting.
- Draft Health Hazard Assessments, field action board meeting minutes and utilize customer requirements management software to complete field action tasks.
- Stay informed of global regulations related to vigilance reporting and field actions.
- Advise external stakeholders on investigation requirements for vigilance reporting and field actions.
- Represent the vigilance and / or field action function on complex, cross-functional project teams, and inform on regulatory risks.
- Clearly communicate aspects of vigilance and / or field actions to Vigilance Operations Team (VOT) management and external team management.
- Draft and own departmental procedures (SOPs and work instruction documents and associated templates).
- 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 :
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 :
Knowledge, Skills, Abilities :
The ability to work closely with management to identify and communicate areas of technical, schedule, and budget risk.
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 https : / / careers.biomerieux.com / or contact us at recruitment@biomerieux.com .
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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