Principal MDR - Vigilance Specialist

Medtronic Diabetes Business Role

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.

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.

Required Knowledge and Experience

Minimum 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 Have

• 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

You will be required to work on-site at our Northridge, CA location a minimum of 3 days per week. This on-site presence is crucial to fostering collaboration and maintaining a strong connection with our team and the workplace environment. Your direct manager will be your point of contact to help you navigate and ensure a seamless integration into our workplace culture. Your manager will be available to connect with you on your on-site days, providing guidance, support, and facilitating your successful transition into your role. Please note, hybrid work arrangements are subject to change due to business needs, and more days on-site may be required.

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) : $129,600.00 - $194,400.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). U.S. Pay Transparency (for SIP, Commission, Hourly Direct, Interns, Executives) 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, 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.

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.