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Senior Medical Safety Specialist

$107.2k - $160.8k

Medtronic plc

Senior Medical Safety Specialist, Cardiac Ablation SolutionsCareers 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.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 ResponsibilitiesIdentify, 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 QualificationsBachelor'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 QualificationsExperience 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 RequirementsThe 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 described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.U.S. Work Authorization & SponsorshipAt Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Please keep the following in mind:Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io & CompensationMedtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.Salary ranges for U.S (excl. PR) locations (USD):$107,200.00 - $160,800.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.Further details are available at the link below:Medtronic benefits and compensation plansIt is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status,

Vacancy posted 1 day ago
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