Clinical QA Specialist

Job description

Are you passionate about ensuring compliance and patient safety in the medical device industry? At Hologic, 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, including Technical Service, Marketing, Sales, and Regulatory, to ensure timely and thorough documentation, analysis, and reporting. If you thrive in a fast-paced, collaborative environment and have a strong background in regulatory compliance and quality assurance, this is your opportunity to make a meaningful impact on healthcare innovation. Knowledge: Skills: Behaviors: Experience: - 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, noti...