Clinical QA Specialist

We are seeking a Clinical QA Specialist to play a critical role in the investigation and reporting of potential and actual adverse events, as well as other regulatory reporting activities. In this role, you’ll collaborate with cross-functional teams to ensure timely and thorough documentation, analysis, and reporting.

Requirements

• Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management.
• Strong knowledge of medical procedures and the expected and potential outcomes related to Hologic’s product portfolio.
• Familiarity with post-market surveillance requirements, adverse event reporting, and health risk assessments.
• Awareness of regulatory reporting processes, including MedWatch reports, notified body communications, and external notifications.
• Proven ability to independently collect, analyze, and assess information associated with adverse events and determine appropriate next steps.
• Effective communication skills to interact with internal teams, sales personnel, customers, patients, and regulatory agencies.
• Strong organizational skills to ensure timely documentation, reporting, and follow-up of adverse events and regulatory submissions.
• Analytical skills to support and lead investigations, including CAPAs, nonconformances, and other quality system processes.
• Ability to innovate and improve processes to enhance efficiency and compliance with post-market surveillance requirements.
• Proficient in leading or participating in internal and external audits, inspections, and assessments.