Vigilance Expert

The Vigilance Expert – Molecular serves as a subject matter expert responsible for global and regional vigilance activities across the product lifecycle. This role ensures regulatory compliance, evaluates risks, and oversees field actions and adverse event reporting for molecular products.

The position leads complex, cross-functional initiatives, supports regulatory interactions, and provides guidance and mentorship to team members to ensure high standards of patient safety and compliance.

Key Responsibilities

• Assess and manage product complaints with a focus on patient safety and regulatory compliance (FDA, EU IVDR, MDR)
• Review, approve, and submit vigilance reports to regulatory authorities (MDR, eMDR, MIR, trend reports)
• Lead cross-functional discussions (e.g., Field Action Board) to evaluate risks and determine corrective actions
• Serve as a primary contact with regulatory authorities, coordinating responses and communications
• Support audits and inspections; contribute to Post Market Surveillance (PMS) activities and trend analysis
• Monitor and report on quality metrics and QMS indicators; present findings as needed
• Ensure adherence to internal procedures and drive continuous improvement initiatives
• Provide mentorship and guidance to specialists and cross-functional teams

Additional Responsibilities

• Contribute to product risk assessments and executive communications
• Facilitate collaboration across teams and franchises to improve processes and compliance
• Support workload balancing activities across vigilance teams
• Perform all duties in accordance with company quality systems and policies

Qualifications

Education

• Bachelor’s degree in a scientific field (e.g., biology, biotechnology, medical laboratory science, pharmacology), and 7+ years of experience in vigilance, regulatory, or quality within IVD/medical device environments
  • OR HS Diploma/GED and 11+ years of experience in vigilance, regulatory, or quality within IVD/medical device environments

Preferred

• Advanced knowledge of global regulations (21 CFR, EU IVDR, MDR)
• Experience leading cross-functional projects and managing time-sensitive deliverables
• Master’s degree or higher

Knowledge, Skills & Abilities

• Strong expertise in vigilance regulations and quality systems (ISO 13485, FDA, MDSAP)
• Ability to assess risk and make independent decisions
• Strong communication skills, including presenting complex technical information
• Proven ability to collaborate across functions and influence stakeholders
• Strong problem-solving and analytical skills
• Proficiency in Microsoft Office tools (Outlook, Teams, Word, Excel)

Minimal travel required (approximately 5% domestic)

The estimated salary range for this role based in Utah is between $131,300 – 158,900. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer. 

In addition, bioMérieux offers a competitive Total Rewards package that may include: 

·        A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options 

·        Company-Provided Life and Accidental Death Insurance 

·        Short and Long-Term Disability Insurance 

·        Retirement Plan including a generous non-discretionary employer contribution and employer match. 

·        Adoption Assistance 

·        Wellness Programs 

·        Employee Assistance Program 

·        Commuter Benefits 

·        Various voluntary benefit offerings 

·        Discount programs 

·        Parental leaves