Job Description

Description

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...

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