We anticipate the application window for this opening will close on - 5 Jul 2025

 

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.

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 

Must Haves

Bachelor’s Degree with 7+ years of Quality and/or Regulatory experience OR advanced degree with 5+ years of Quality and/or Regulatory experience

Nice to Have

• Demonstrated ability to collaborate and influence in a matrixed environment and to work effectively with in-house functional team

• 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 requir