Principal Product Complaint Analyst
Core
Lead strategic initiatives to enhance product quality and performance, ensuring compliance with regulatory requirements for medical device complaint handling and reporting.
Role type
Principal Product Complaint Analyst
Builds
Post-market quality improvement projects and standardized complaint handling processes
Domain
Medical device industry / Regulatory compliance
Deliverable
dashboards & analysis
Required skills
Project management, Regulatory compliance (FDA, ISO, MDR), Data analytics, Systems thinking, Risk identification, Process improvement
Preferred skills
Post-market vigilance experience, CAPA experience, SAS/Snowflake querying, Technical writing
Technologies
Microsoft Office (Word, Excel, PowerPoint, Visio), SAS, Snowflake
Responsibilities
Ensure compliance with U.S. and international regulatory requirements for complaint handling; Lead large-scale projects to improve post-market quality; Coordinate cross-functional stakeholders; Present deliverables to senior leadership; Provide audit support; Develop and manage improvement plans; Identify and escalate risks; Implement new standard operating procedures.
Seniority
Principal, strategic leadership & cross-functional influence