Principal Medical Safety Specialist - CRMDx
Boston Scientific
Summary
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.
Job description
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.
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.
Requirements
- 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.
- 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.
Benefits
- Health insurance
- Annual bonus target
- Long-term incentives
Company overview
Boston Scientific Corporation is a global leader in the development, manufacturing, and marketing of minimally invasive medical devices used in interventional medical specialties. Founded in 1979 and headquartered in Marlborough, Massachusetts, the company focuses on transforming patient lives through innovative medical solutions across a wide range of therapeutic areas including cardiology, endoscopy, urology, pulmonology, and neuromodulation. With approximately 53,000 employees worldwide and operations in 40 countries, Boston Scientific serves over 44 million patients annually. The company invests heavily in research and development, allocating $1.6 billion to R&D in 2024, and maintains a strong commitment to quality, patient safety, and meaningful innovation. Boston Scientific's product portfolio includes advanced technologies such as cardiac rhythm management devices, coronary stents, ablation systems, endoscopy equipment, and neuromodulation therapies, all designed to improve patient outcomes and quality of life through less invasive treatment options.