We anticipate the application window for this opening will close on - 13 Feb 2026
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
The Clinical Safety Specialist is responsible for safety and potential complaint data throughout the clinical study to ensure compliance with respect to the reporting of clinical study safety and potential complaint data to meet regulatory requirements. The MCRS Clinical Safety Specialist will partner with various colleagues across Medtronic (e.g., other members of the MCRS Clinical Safety team, other MCRS functions, Regulatory Affairs, Clinical teams in the Operating Units) to manage adverse event, death, and device deficiency reporting in compliance with applicable regulatory standards and Medtronic internal requirements.
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.
Responsibilities may include the following and other duties may be assigned.
Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies
Review non-AE Case Report Forms to detect potential complaint and potential unreported AEs
Interact with investigational sites and clinical monitors to obtain additional pertinent information as indicated in the Clinical Investigation Plan (CIP)
Ensure consistency in the assessment of clinical safety events
Work with Regulatory Affairs and the Product Complaint Reporting teams to ensure timely reporting of AEs, SAEs, and Unanticipated Serious Adverse Device Effects (U[S]ADEs) and potential complaints
Ensure appropriate distribution and notification of SAEs and U[S]ADEs to appropriate personnel, partners, and investigational sites per CIP
Act as liaison for safety-related questions (e.g., to study team, field support, monitors, and study sites)
Author Clinical Safety Management and Potential Complaint Plan (CSMPCP) for assigned studies
Assist with preparation of assigned section of safety reports for annual reports, clinical study reports, and other documents as required
Collaborate with Data Management and other departments on the development of case report forms, study specific safety reports, and other study specific forms
Assist with the writing of safety sections of CIPs and may present Clinical Safety requirements at investigator meetings
Support study audit for Safety-specific topics
Facilitate Clinical Event Committee (CEC) work (author CEC charter, review source documents, ensure all CEC events are adjudicated by CEC)
Support database snapshot activities (e.g., meet with study team, review timelines, perform reconciliation and data cleaning activities to be audit & snapshot ready)
Prepare, attend and/or lead Safety Trending meetings
Perform other Clinical Safety tasks as assigned
Minimum Requirements:
• Bachelor’s degree
• 2+ yrs safety experience
• Previous Medtronic experience
• Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
• Fluent with medical terminology
Nice to Have:
• Good written, oral, and interpersonal communication skills including knowledge of medical terminology.
• Proficient with MS Office products, word processing, spreadsheets, etc.
• High attention to detail and accuracy and ability to manage multiple tasks.
• Good prioritization and organizational skills.
• Excellent problem solving skills
• Flexible and dependable.
• Works effectively on cross-functional teams.
• RN, PA or allied health professional including Biomedical Engineer, Biomedical Scientist, will work on Cardiac device trials Coordinator
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.
Benefits & Compensation
Medtronic 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):$83,200.00 - $124,800.00This 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, andSimple 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), andCapital 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
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
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.
