Senior Medical Safety Specialist
About The Position
The Senior Medical Safety Specialist, Cardiac Ablation Solutions, provides clinical and technical expertise to support patient safety activities across cardiac ablation technologies, procedures, and therapies. The role evaluates safety information and potential risks, supports post-market surveillance, and collaborates with cross-functional partners to inform safety-related decisions throughout the product lifecycle. 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. This is a remote position requiring up to 10% travel. The role also leads complex safety assessments and initiatives, serves as a subject matter expert, and mentors team members and cross-functional partners on assigned therapies and safety topics.
Requirements
- Bachelor's degree in Nursing or a healthcare-related field and active healthcare professional licensure.
- At least 4 years of experience in cardiac electrophysiology, cardiac ablation therapies, direct EP mapping-system experience, medical device clinical practice, or a related specialty area; alternatively, an advanced degree and at least 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.
- For baccalaureate degrees earned outside the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice To Haves
- 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.
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 topics.
Benefits
- Competitive salary and flexible benefits package.
- Health insurance.
- Dental insurance.
- Vision insurance.
- Health Savings Account.
- Healthcare Flexible Spending Account.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Tuition assistance/reimbursement.
- Global well-being program (Simple Steps).
- Incentive plans, including the Medtronic Incentive Plan (short-term incentive).
- 401(k) plan with employer contribution and match.
- Short-term disability.
- Paid time off.
- Paid holidays.
- Employee Stock Purchase Plan.
- Employee Assistance Program.
- Non-qualified Retirement Plan Supplement, subject to IRS earning minimums.
- Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
