Principal Medical Safety Specialist - CRMDx

Principal Medical Safety Specialist - CRMDxWork mode: Hybrid Onsite Location(s): Arden Hills, MN, US, 55112 Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.About the role: The Principal Medical Safety Specialist provides medical and clinical safety expertise across the total product lifecycle for cardiology and electrophysiology products and therapies. This role performs medical assessments of adverse events; evaluates emerging safety signals and product performance trends; and provides clinical input into risk management, post-market surveillance, and patient safety decisions. As a Medical Safety subject matter expert, this individual partners closely with the Medical Director and cross-functional teams across Quality, Regulatory, Clinical, R&D, Medical Affairs, and Commercial functions to evaluate complex safety issues and support informed benefit-risk and patient safety decisions.Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three (3) days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Your responsibilities will include:Serve as a Medical Safety subject matter expert on cross-functional teams supporting product development, risk management, post-market surveillance, quality investigations, and remediation activitiesApply advanced clinical and technical knowledge of cardiology, electrophysiology, and cardiac implantable electronic devices (CIEDs) to assess device safety, product performance, and potential patient impactPerform 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 sourcesLead the evaluation of complex or emerging safety signals, trends, and product performance concerns, providing clinical assessments and recommending appropriate escalation or risk mitigationProvide medical expertise for complaint review boards, corrective and preventive actions (CAPAs), nonconforming event processes (NCEPs), product investigation reports (PIRs), and other applicable quality system processesAnalyze data from multiple sources and communicate concise, clinically-meaningful safety assessments and recommendations to the Medical Director, cross-functional teams, and leadershipProvide medical review and input for risk management documentation, labeling, instructions for use (IFUs), product safety communications, post-market surveillance, and regulatory deliverablesReview promotional, educational, and sales training materials for medical and clinical accuracy, as applicableIdentify opportunities to improve Medical Safety processes and practicesApply knowledge of applicable global medical device regulations, standards, and reporting requirementsRequired qualifications:Bachelor's degree in health care, life sciences or a related fieldActive professional licensure as a registered nurse (RN), advanced practice registered nurse/nurse practitioner (APRN/NP), or physician assistant (PA)Minimum of five (5) years of experience in direct patient care, including a minimum of two (2) years of experience in cardiology and/or electrophysiology with advanced CIED interrogation and troubleshooting experienceStrong clinical judgment and analytical skills, with the ability to interpret complex medical, scientific and product performance informationDemonstrated ability to make sound independent decisions, navigate ambiguity, manage competing priorities and lead complex work with minimal supervisionExcellent technical writing and verbal communication skills, with the ability to clearly communicate complex clinical and safety informationDemonstrated ability to build effective cross-functional relationships and influence without formal authorityPreferred qualifications:Recent experience in a field-based clinical role providing clinical and technical support for CIED implant proceduresAdvanced experience with cardiac rhythm management (CRM) technologies, including pacemakers, implantable cardioverter-defibrillator (ICDs), cardiac resynchronization therapy (CRT) devices, subcutaneous implantable cardioverter-defibrillator (S-ICD) systems, leadless pacing systems, cardiac monitoring systems, and device interrogation and troubleshootingMinimum of 2 years of experience in Medical Safety, Clinical Research, Clinical Quality, or a related medical device functionExperience with safety signal evaluation, risk management, post-market surveillance, quality investigations, and/or benefit-risk assessmentsWorking knowledge of global medical device regulations and requirementsExperience working within a regulated medical device quality system and across multidisciplinary teams