Senior Product Analyst
Core
Analyze customer complaints and regulatory compliance within the Neuromodulation Division's Complaint Management Center to identify risks and improve patient safety.
Role type
Senior Product Analyst (Medical Device Quality & Compliance)
Builds
Regulatory reports, hazard analyses, and corrective action plans for medical devices.
Domain
Medical Devices / Neuromodulation / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Regulatory compliance analysis, hazard analysis (DFMEA), clinical knowledge, 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 using clinical knowledge and lab analyses; establish regulatory reportability decisions; apply appropriate coding to complaint events; compose written communications for physicians and customers; support divisional initiatives and process improvements.
Seniority
Senior, hands-on IC