Sr. Associate Specialist, Product Surveillance, Clinical WHXR
GE HealthCare
September 16, 2026
Full-time
Remote friendly (Waukesha, WI)
Worldwide
Operations
Role: Manage complaint handling activities and support Quality & Regulatory functions to ensure the safety and effectiveness of GE Healthcare's medical devices. Main objectives include clinical evaluation of customer complaints, risk assessment, and ensuring regulatory compliance (21CFR part 803). Responsibilities: review complaints using clinical and real-world workflow knowledge, evaluate patient safety impact, communicate complex technical info clearly, collaborate with cross-functional teams (Medical Safety, Engineering, Regulatory), and support complaint investigations and reporting. Qualifications: Bachelor's degree or equivalent with at least 2 years of clinical experience interfacing with X-Ray, Mammography, or Bone Density devices; experience in medical device manufacturing or clinical settings. Preferred skills include product-specific knowledge, familiarity with 21CFR Part 820, proficiency in Microsoft Office, and experience with process improvements and cross-team collaboration. HighValue: medical devices (X-Ray, Mammography, Bone Density), complaint management, regulatory compliance, patient safety, cross-functional teamwork. WorkSetup: not specified; relocation assistance provided.