Senior Medical Safety Specialist
Medtronic Plc
We anticipate the application window for this opening will close on - 9 Nov 2026
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
The Medical Safety team provides clinical expertise and patient safety oversight across the product lifecycle, partnering with Research & Development, Quality, Regulatory Affairs, Clinical, Risk Management, and Post-Market Vigilance teams. The Cardiac Ablation Solutions Medical Safety team evaluates product performance, safety signals, adverse events, and emerging risks to support evidence-based decision-making and help ensure the safety and effectiveness of cardiac ablation technologies.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require up to 10% of travel to enhance collaboration and ensure successful completion of projects.
As a Senior Medical Safety Specialist, Cardiac Ablation Solutions, you will provide clinical and technical expertise to support patient safety activities across Cardiac Ablation technologies, procedures, and therapies. You will evaluate safety information, assess potential risks, support post-market surveillance activities, and collaborate with cross-functional partners to inform safety-related decisions throughout the product lifecycle.
Primary Responsibilities
- Identify, evaluate, and communicate safety signals, emerging risks, and adverse event trends using post-market, clinical, and scientific data sources.
- Conduct medical safety assessments using complaint data, scientific literature, registries, and post-market surveillance information.
- Apply knowledge of electroanatomic mapping, intracardiac signal interpretation, lesion delivery, catheter-tissue interaction, and procedural workflow when evaluating complaints, adverse events, product performance, and potential patient safety risks.
- Respond to safety-related inquiries from internal stakeholders, healthcare professionals, and regulatory agencies.
- Collaborate with Medical Safety, Clinical, Regulatory Affairs, Risk Management, and Quality teams to assess and address emerging safety concerns.
- Support risk management activities, including hazard evaluation, risk assessments, and benefit-risk analyses throughout the product lifecycle.
- Maintain advanced knowledge of cardiac electrophysiology, cardiac ablation therapies, mapping technologies, and associated clinical procedures.
- Provide evidence-based medical input to support safety reviews, risk assessments, and regulatory reporting activities.
- Lead complex safety assessments and initiatives that improve patient safety practices, business processes, and cross-functional decision-making.
- Serve as a subject matter expert and mentor to team members and cross-functional partners on assigned therapies and safety topic.
Required Qualifications
- Bachelor's degree in Nursing or healthcare-related field and active healthcare professional licensure.
- Minimum of 4 years of experience in cardiac electrophysiology, cardiac ablation therapies, direct EP mapping-system experience, medical device clinical practice, or a related specialty area OR advanced degree and 2+ years of related experience.
- Direct experience using, supporting, or providing clinical expertise for electroanatomic mapping systems during cardiac ablation procedures.
- Experience in Medical Safety, Medical Affairs, Clinical Management, or related clinical healthcare functions.
- Experience evaluating clinical, safety, or post-market data to support risk-based decision-making.
Preferred Qualifications
- Experience with electrophysiology mapping systems and catheter-based ablation technologies.
- Knowledge of the clinical management of cardiac arrhythmias and catheter-based interventions.
- Medical device industry experience.
- Knowledge of Food and Drug Administration (FDA), European Medicines Agency (EMA), or other medical device regulatory requirements.
- Experience with statistical analysis, safety analytics, Microsoft Word, Excel, or related systems.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands describe
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