Principal Medical Safety Specialist
Core
Principal Medical Safety Specialist responsible for medical review of adverse event data and safety signal evaluation for cardiology, electrophysiology, and LAAO products.
Role type
Principal Medical Safety Specialist (Clinical/Regulatory)
Builds
Medical safety assessments, risk management documentation, and regulatory deliverables for medical devices.
Domain
Medical Device / Cardiology / Electrophysiology
Required skills
Medical device regulations, adverse event assessment, safety signal evaluation, clinical judgment, technical writing, cross-functional collaboration, product lifecycle knowledge, risk mitigation, regulatory reporting, data analysis
Preferred skills
Medical Safety experience, Risk Management, Clinical Research, Clinical Quality, Medical device industry experience
Technologies
Microsoft 365
Responsibilities
Perform medical review and assessment of adverse events from clinical trials and post-market data; Lead evaluation of complex safety signals and trends; Provide medical expertise for complaint review boards and CAPAs; Analyze data and communicate safety assessments to leadership; Review promotional materials for clinical accuracy; Identify opportunities to improve Medical Safety processes.
Seniority
Principal, hands-on IC with strategic oversight