Principal Medical Safety Specialist - CRMDx

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 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. The Principal Medical Safety Analyst 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. Work model, sponsorship, relocation 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 days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available 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 activities. Apply advanced clinical and technical knowledge of cardiology, electrophysiology and cardiac implantable electronic devices (CIEDs) 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. Lead the evaluation of complex or emerging safety signals, trends and product performance concerns, providing clinical assessments and recommending appropriate escalation or risk mitigation. 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. Review promotional, educational and sales training materials for medical and clinical accuracy, as applicable. Identify opportunities to improve Medical Safety processes and practices. Apply knowledge of applicable global medical device regulations, standards and reporting requirements. Qualifications Required qualifications: Bachelor's degree in health care, life sciences or a related field. Active professional licensure as a registered nurse (RN), advanced practice registered nurse/nurse practitioner (APRN/NP) or physician assistant (PA), as applicable. Minimum of 5 years' direct patient care experience, including a minimum of 2 years' experience in cardiology and/or electrophysiology with advanced CIED interrogation and troubleshooting experience. 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. Preferred Qualifications Recent experience in a field-based clinical role providing clinical and technical support for CIED implant procedures. Advanced experience with cardiac rhythm management (CRM) technologies, including pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, subcutaneous implantable cardioverter-defibrillator (S-ICD) systems, leadless pacing systems, cardiac monitoring systems, and device interrogation and troubleshooting. Minimum of 2 years' experience in Medical Safety, Clinical Research, Clinical Quality or a related medical device function. Experience with safety signal evaluation, risk management, post-market surveillance, quality investigations and/or benefit-risk assessments. Working knowledge of global medical device regulations and requirements. Experience working within a regulated medical device quality system and across multidisciplinary teams. Minimum Salary: $ 102100 Maximum Salary: $ 194000 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at follow us onLinkedIn. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. #J-18808-Ljbffr Boston Scientific