Principal Medical Safety Specialist

Your responsibilities will include: Apply advanced clinical and technical knowledge of cardiology and electrophysiology to assess device safety, product performance and potential patient impact. Perform medical review and assessment of adverse events and potential adverse events from clinical trials, post-market complaints, Medical Device Reports (MDRs) and other relevant data sources. Provide medical expertise for complaint review boards, corrective and preventive actions (CAPAs), nonconforming event processes (NCEPs), product investigation reports (PIRs) and other applicable quality system processes. Analyze data from multiple sources and communicate concise, clinically meaningful safety assessments and recommendations to the Medical Director, cross-functional teams and leadership. Provide medical review and input for risk management documentation, labeling, instructions for use (IFUs), product safety communications, post-market surveillance and regulatory deliverables. Apply knowledge of applicable global medical device regulations, standards and reporting requirements. Bachelor's or advanced degree in a health care, life sciences or related field. Active, unencumbered professional licensure as a registered nurse (RN), doctor of nursing practice (DNP) or physician assistant (PA). Minimum of 5 years' direct patient care experience, including a minimum of 3 years' electrophysiology lab experience, with preferred experience supporting pulsed field ablation (PFA) and LAAO procedures, or field experience working with PFA. Experience with Microsoft 365. Proven ability to work independently and autonomously. Strong clinical judgment and analytical skills, with the ability to interpret complex medical, scientific and product performance information. Demonstrated ability to make sound independent decisions, navigate ambiguity, manage competing priorities and lead complex work with minimal supervision. Excellent technical writing and verbal communication skills, with the ability to clearly communicate complex clinical and safety information. Demonstrated ability to build effective cross-functional relationships and influence without formal authority. Minimum of 2 years' related experience in Medical Safety within the medical device industry, Risk Management, Clinical Research and/or Clinical Quality. Recent industry experience. Medical device experience.