Principal MDR - Vigilance Specialist

Medtronic•Northridge, CA

1d•Hybrid

About The Position

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 In this role, you will work with a team that monitors Medtronic’s surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations. Key Responsibilities: This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. People-centered, data-driven, connected. We're solving the world's biggest health challenges with healthcare technology. We fuse technology and research for groundbreaking solutions. From less-invasive surgery that minimizes a patient's downtime to the world’s smallest pacemaker, our technology transforms lives

Requirements

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.

Nice To Haves

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

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

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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)