Product Quality Clinician
Core
Provide clinical expert knowledge and guidance to quality specialists for assessing medical device complaints, evaluating health risks, and supporting regulatory decision-making in structural heart therapies.
Role type
Senior Product Quality Clinician (Medical Devices)
Builds
Clinical risk assessments, regulatory submissions, and quality monitoring dashboards for structural heart products.
Domain
Medical Devices / Structural Heart / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical expert knowledge, risk evaluation, data analysis, regulatory reporting, medical device regulations, complaint investigation, training development, data visualization, stakeholder management
Preferred skills
AI-enabled tools usage, advanced Excel, QMS expertise, project management, international quality system regulations
Technologies
Microsoft Office Suite, QMS, AI-enabled tools
Responsibilities
Analyze aggregate complaint and clinical data for trend identification; Provide clinical input to Product Risk Assessments; Develop data visualization tools and dashboards; Mentor and train quality specialists on medical aspects and procedures; Obtain and evaluate information from clinical specialists and physicians to support investigations; Support regulatory submissions with clinical data.
Seniority
Senior, hands-on IC with mentorship responsibilities