Post Market Surveillance Specialist I

Own post-market surveillance and regulatory reporting for ZOLL devices, including assessing events against FDA and international requirements for adverse event reporting. Generate required regulatory submissions, coordinate complaint record closure in the PMS system, and support competent authority inquiries, serious injury reporting, and risk management. Collaborate across Quality Engineering, Compliance, Technical Support, Service, and Regulatory Affairs, and assist with audits, documentation review, and status reporting.