Senior Product Complaint Analyst
Core
Analyze customer complaints within the Neuromodulation Division's Complaint Management Center to ensure regulatory compliance, assess patient safety risks, and drive process improvements.
Role type
Senior Product Complaint Analyst (Medical Devices)
Builds
Regulatory reports, hazard analyses, and corrective action plans for neuromodulation and implantable medical devices.
Domain
Medical Devices / Regulatory Compliance / Quality Management
Required skills
Regulatory compliance (FDA/ISO), clinical knowledge, hazard analysis (DFMEA), data analytics, technical writing, stakeholder influence
Preferred skills
CAPA experience, neuromodulation product knowledge, data analytics for quality decisions, leadership presentation
Technologies
Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Review complaint communications for regulatory compliance and patient safety impact; conduct investigations by gathering information from clinical staff and labs; establish regulatory reportability decisions using hazard analyses; apply appropriate coding to complaint events; compose comprehensive written communications for physicians and customers; support divisional initiatives and strategic priorities.
Seniority
Senior, hands-on IC