Medtronic · 11 hours ago
Clinical Safety Specialist
United States
Full-time
Remote
Entry, Mid Level
$83K/yr - $125K/yr
2+ years expMedtronic is a global leader in healthcare technology, dedicated to alleviating pain and restoring health. The Clinical Safety Specialist is responsible for managing safety and complaint data during clinical studies to ensure compliance with regulatory requirements and internal standards.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
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
Qualification
Required
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
Preferred
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
Benefits
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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
BioWorld Financial Watch
2026-01-25
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