Medtronic · 5 months ago
Principal MDR - Vigilance Specialist
Los Angeles, California, United States of America
Full-time
Hybrid
Senior Level, Lead/Staff
$130K/yr - $194K/yr
5+ years expMedtronic is a leader in global healthcare technology, committed to addressing challenging health problems through innovative solutions. The Principal MDR - Vigilance Specialist will oversee Medtronic’s surveillance program, ensuring compliance with regulatory requirements and managing adverse reports. This role involves collaboration with cross-functional teams to enhance patient care through effective project management and regulatory adherence.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies
Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries
Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
Lead or leverage cross functional teams to evaluate, develop and manage projects for key business processes
Oversee and manage the operational aspects of ongoing projects and serves as liaison between project team and stakeholders
Assess project issues and supports project team in development of resolutions to meet goals and objectives
Understand current and upcoming Medical Device Reporting (MDRs) and EU Vigilance Reporting requirements by regulatory bodies and ensure adequate implementation or regulations
Qualification
Required
Bachelor's Degree with 7+ years of experience in Quality and/or Regulatory, including direct experience in MDR/vigilance systems implementation
OR Advanced degree with 5+ years of relevant experience in the same areas
Preferred
10+ years' experience working with CAPA, Management Review, Change Control and Audit processes
Experience with TrackWise software
Working knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc
Previous experience with effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques
Experience with quality tools and process improvement techniques
Experience reviewing technical documentation
Demonstrated ability to collaborate and influence in a matrixed environment and to work effectively with in-house functional team
Strong Regulatory Compliance experience – understanding, interpreting and implementing Regulatory changes into policies/processes
Excellent verbal, written and presentation communication skills
Proven ability to build and facilitate strong, productive working relationships with a wide variety of cross-functional and customer contacts
Program management experience in the medical device, aerospace, automotive or other highly regulated industry
Experience devising and implementing streamlined processes and strategic programs to improve efficiency, timeliness, and productivity
Experience in leading within matrix organizations requiring strong influence management skills
Change agent --willingness and ability to lead and institute change
Influence management skills; experience working collaboratively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals
Excellent communication skills and interpersonal/team effectiveness with ability to succinctly and accurately communicate to various levels of management and employees
Business acumen; ability to think and act from an overall 'best for the business' perspective
Results oriented; strong sense of urgency
Strong analytical, planning, organization and time management skills to effectively develop and execute comprehensive programs and budgets
Effective decision-making skills with ability to negotiate and balance decisions and priorities across needs of several functional departments and willingness to make tough decisions
Makes timely decisions in the face of risk and uncertainty
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
Medical Device Network
2026-01-16
Mexico Business
2026-01-16
Medical Product Outsourcing
2026-01-16
Company data provided by crunchbase