Senior Medical Safety Specialist

• →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.

• 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.

• 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.

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.

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.

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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. 

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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. 

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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 plans

It 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, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.