Quality, Nurse Specialist
Core
Clinical specialist supporting regulatory, clinical, and quality functions for medical devices, acting as a bridge between healthcare professionals and product teams.
Role type
Registered Nurse (RN) Quality Specialist
Builds
Clinical support for investigational and marketed device studies, product labeling reviews, and regulatory responses.
Domain
Medical Technology / Healthcare
Deliverable
client delivery | dashboards & analysis
Required skills
Clinical nursing expertise, regulatory compliance knowledge, customer complaint investigation, cross-functional collaboration, medical device reporting (MDR) determination, product labeling review
Preferred skills
Central venous access device management (PICC, CVC, dialysis catheters, ports), infusion administration, device maintenance and troubleshooting, clinical quality management experience
Technologies
Medical devices (PICCs, CVCs, dialysis catheters, implanted ports)
Responsibilities
Interface with upper management on regulatory and clinical issues; respond to clinical inquiries; provide field assurance support for customer complaints; identify clinical concerns with accounts; provide clinical input to product teams; support device studies; participate in design reviews; review product labeling for accuracy; serve as clinical resource for cross-functional teams; determine MDR status; review complaint files; assist regulatory authority responses; provide support to Clinical Education and Marketing teams
Seniority
Entry-level to Mid-level, hands-on IC