Principal Medical Safety Specialist - CRMDx

Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough

Diversity
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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…