Oferta de trabajo: Regulatory and Quality Compliance Expert

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:

• 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:

• 7+ years in regulatory affairs or equivalent regulated industry employment position, medical device/IVD industry preferred

• 4+ years leading projects

Knowledge, Skills, Abilities:

• Ability to think strategically, identify and mitigate regulatory risks and maintain regulatory compliant processes and procedures.

• Must demonstrate strong project ownership skills and peer mentorship skills.

• Personable and service or iented with attention to detail, excellent organizational and time management skills.

• Excellent written and verbal communication skills, including justification for vigilance related decisions or processes.

• Skill to work in an... For full info follow applicat on link.