Senior Medical Safety Specialist

Medtronic Mounds View, Minnesota, United States of America Updated 2 October 2026
MedTechPharmaPharmacovigilanceClinical ResearchRegulatory AffairsQuality Assuranceheormedicalemafdaiso 13485croraveinform

Job description

We anticipate the application window for this opening will close on - 4 Oct 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 Coronary and Renal Denervation Medical Safety team supports patient safety activities across the product lifecycle, partnering with Clinical, Regulatory Affairs, Quality, Risk Management, Medical Affairs, Product Development, and Post-Market Vigilance teams. The team evaluates safety data, assesses potential safety signals, supports risk management activities, and provides medical expertise to guide safety-related decision-making for coronary artery disease and renal denervation therapies. 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 10% of travel to enhance collaboration and ensure successful completion of projects. As a Senior Medical Safety Specialist, you will provide clinical and medical expertise to support patient safety activities across coronary and renal denervation therapies. You will evaluate safety information, assess potential safety signals, contribute to risk management activities, and collaborate with cross-functional teams to support product safety throughout the product lifecycle. Primary Responsibilities Evaluate adverse events, complaint data, literature, registries, and other safety information to identify and assess potential safety signals. Author medical safety assessments and recommendations to support product safety reviews and regulatory reporting activities. Provide medical and clinical input to Quality, Regulatory Affairs, Risk Management, Clinical, Medical Affairs, and Product Development teams. Assess and escalate emerging safety concerns and support investigations, risk assessments, and corrective actions. Perform qualitative and quantitative analyses of post-market safety data and contribute to annual and periodic regulatory reports. Support responses to safety-related inquiries from internal stakeholders, healthcare professionals, regulatory agencies, and health organizations. Maintain expertise in assigned therapies, product technologies, applicable regulations, and risk management processes. Lead initiatives that enhance safety practices, improve business processes, and support evidence-based decision-making across the organization. Required Qualifications Bachelor's degree in Nursing or a healthcare-related field and licensed healthcare professional status. Minimum of 4 years of experience in coronary artery disease and renal denervation management OR advanced degree with 2+ years of related experience. Knowledge of coronary artery disease, hypertension management, and interventional cardiology technologies including balloons, catheters, stents, or renal denervation devices. Experience in Medical Safety, Medical Affairs, Clinical Research, Clinical Management, or related healthcare functions. Experience evaluating clinical or post-market safety data and supporting patient safety activities. Preferred Qualifications Medical device industry experience supporting cardiovascular, coronary, or renal denervation therapies. Experience with risk management, post-market vigilance, complaint handling, or regulatory reporting processes. Experience interpreting scientific literature, clinical evidence, and safety data to support medical decision-making. Knowledge of Food and Drug Administration (FDA), European Medicines Agency (EMA), ISO 13485, ISO 14971, and related medical device regulations and standards. Proficiency with Microsoft Office applications and experience performing data analysis or statistical assessments. 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 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 & Sponsorship At 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 Alert We 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 AskHR@medtronic.com . ‌ Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package

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