Complaints Handler

Seeking a Complaints Engineer to support post-market surveillance activities for globally distributed medical devices. This role will manage complaint handling, vigilance reporting, regulatory compliance, and quality escalation processes to ensure product safety, customer satisfaction, and adherence to international medical device regulations. Responsibilities Manage escalated complaint intake for a designated region (EMEA, APAC, or Americas) Review incoming complaints for completeness, accuracy, and regulatory compliance Perform regional and global reportability assessments Draft and submit vigilance reports to regulatory authorities Prepare and communicate customer responses to escalated complaints Serve as an escalation point for regulators, customers, and internal stakeholders on product quality issues Support investigation and resolution of product quality concerns through established escalation processes Identify adverse trends and support risk assessment activities Participate in internal and external audit preparation and serve as an SME during audits Maintain and update complaint handling procedures in alignment with Quality Management System requirements Support continuous improvement of complaint handling workflows and compliance processes Qualifications Bachelor’s degree in Engineering, Science, or related field Experience in medical device complaint handling and vigilance activities Strong understanding of global medical device complaint and vigilance regulations (FDA, EU MDR, Health Canada, ANVISA, TGA) Experience supporting regulatory inspections, audits, or MDSAP activities Strong analytical and problem-solving skills Excellent technical writing and verbal communication abilities Strong organizational and time management skills Ability to work independently and manage evolving regulatory and quality issues Continuous improvement mindset with strong conceptual thinking skills Formal training in Quality Systems or Six Sigma preferred Experience in ISO, MDSAP, EU MDR, or other regulated quality-driven environments preferred #J-18808-Ljbffr Cypress HCM