Medtronic plc
Principal MDR - Vigilance Specialist
Medtronic plc, Los Angeles, California, United States, 90079
We anticipate the application window for this opening will close on - 23 Jan 2026At 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; 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.**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.***Physical Job Requirements**The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.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 #J-18808-Ljbffr
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; 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.**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.***Physical Job Requirements**The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.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 #J-18808-Ljbffr