We anticipate the application window for this opening will close on - 17 Oct 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.

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

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

• 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; expe