Principal Medical Safety Specialist - CRMDx
Core
Principal Medical Safety Specialist providing medical and clinical safety expertise across the total product lifecycle for cardiology and electrophysiology products and therapies.
Role type
Principal Medical Safety Specialist (Clinical/Regulatory)
Builds
Risk management documentation, labeling, instructions for use (IFUs), product safety communications, and regulatory deliverables for cardiology and electrophysiology devices.
Domain
Medical Device / Cardiology / Electrophysiology
Required skills
Medical assessment of adverse events, Safety signal evaluation, Risk management, Post-market surveillance, Clinical judgment, Technical writing, Cross-functional collaboration, Global medical device regulations knowledge
Preferred skills
CIED interrogation and troubleshooting, Cardiac rhythm management technologies, Medical Safety experience, Benefit-risk assessments, Regulated medical device quality system experience
Technologies
CIEDs, Pacemakers, ICDs, CRT devices, S-ICD systems, Leadless pacing systems, Cardiac monitoring systems
Responsibilities
Perform medical review and assessment of adverse events from clinical trials and post-market complaints; Lead evaluation of complex safety signals and trends; Provide medical expertise for complaint review boards and CAPAs; Analyze data to communicate clinically-meaningful safety assessments; Review promotional and training materials for medical accuracy; Identify opportunities to improve Medical Safety processes.
Seniority
Principal, hands-on IC with strategic input