Principal Medical Safety Specialist

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 Specialist is a health care professional responsible for the medical review of adverse event data across a range of products and disease states in cardiology, electrophysiology and left atrial appendage occlusion (LAAO). This individual completes accurate, timely and consistent medical assessments of adverse events and potential adverse events to provide medical expertise and objective oversight and help ensure safety vigilance throughout the total product lifecycle.

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 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.

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.

Acquire and maintain proficient knowledge of assigned products and therapies, including device design and function, product labeling, indications, mechanisms of action, care pathways and overall safety profiles, including hazards and harms.

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 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.

Preferred qualifications:

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.

Requisition ID: 634892

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 www.bscbenefitsconnect.com— will 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 mor