Principal Product Complaint Analyst
Core
Lead global post-market quality initiatives, manage medical device complaint handling and regulatory reporting, and drive cross-functional process improvements to ensure patient safety and product quality.
Role type
Principal Product Complaint Analyst (Quality & Regulatory)
Builds
Global post-market quality systems, standardized complaint handling processes, and regulatory reporting frameworks.
Domain
Medical Device / Healthcare Quality & Regulatory Compliance
Required skills
Project management, systems thinking, data analytics, regulatory compliance knowledge, stakeholder influence, process improvement, risk assessment, technical writing, independent work.
Preferred skills
CAPA processes, SAS/Snowflake querying, advanced technical writing, strategic communication.
Technologies
Microsoft Office Suite (Word, Excel, PowerPoint, Visio), SAS, Snowflake
Responsibilities
Ensure compliance with FDA, ISO, and MDR regulations for complaint handling; lead high-impact projects to improve post-market quality; coordinate cross-functional stakeholders; communicate deliverables to senior leadership; influence decision-making with limited information; provide audit support; develop and implement SOPs; identify and escalate risks; apply systems-thinking to evaluate quality systems.
Seniority
Principal, strategy & mentorship