What are the responsibilities and job description for the MDR/Vigilance Manager position at Medtronic?
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. A career at Medtronic is like no other. We’re purposeful. We’re committed. We’re driven by our Mission to alleviate pain, restore health, and extend life for millions of people worldwide. Join our Neuroscience Customer Quality team to help drive quality on behalf of our patients and customers!
This exciting leadership role will be responsible for leading teams directly supporting the Neurovascular and Neuromodulation Operating Units.
Medtronic is intensely focused on creating a workplace environment that reflects our standing as the world’s top medical device company. The ideal candidate will have a passion for the patients we serve and an unrelenting desire to improve our business.
A Day in the Life
In this exciting role as a MDR/Vigilance Manager, the primary focus of responsibility will be the oversight of teams responsible for complaint handling, medical device reporting, and investigating complaints for Neurovascular and Deep Brain Stimulation products in accordance with global regulatory requirements and internal policies and procedures. This position will directly interface with the Neurovascular and Neuromodulation Operating Unit quality teams to deliver results within several quality KPI’s and strategic initiatives. This role is also responsible for developing and leading initiatives to continuously improve quality and efficiency within your direct organization and as part of the enterprise-wide Customer Quality organization.
Must Have: Minimum Requirements
Responsibilities may include the following and other duties may be assigned.
• Responsible for mentoring, coaching, and developing team members.
• Lead strategic and department level initiatives focused on improving quality and efficiency within the enterprise complaint handling function.
• Define performance goals and targets, conduct performance reviews, hold individual career development conversations, and regular 1:1s with team members to manage toward achieving team goals.
• Serve as subject matter expert to answer complaint related questions and bring complex complaint files to completion.
• Ensure work instructions and procedures are in compliance with all applicable FDA regulations, specifically 21 CFR Parts 820 and 803.
• Maintain regulatory, process and product knowledge to provide internal and external audit support, including front room and back room participation.
• Prioritize and lead/participate in the assessment and solution development for identified issues of moderate to high scope and complexity including CAPAs, non-conformances, and quality assurance action plans.
• Proactively support a “stop and fix” culture driving toward timely resolution of issues using problem solving methodologies such as DMAIC.
• Monitors the company's drug or medical devices 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.
• Ensures 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.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
• Bachelor’s degree required.
• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience
• Proven people leader in a regulated environment supporting complaint handing, engineering, or operations teams.
• Performance-driven critical thinker with strong business acumen.
• Deep knowledge of 21CFR Part 803, 820, and EUMDR.
• Excellent oral and written communications skills with the ability to interface and influence at all organizational levels.
• Ability to coordinate and prioritize multiple demanding tasks in a fast-paced environment.
• Ability to work effectively in a team environment and build strong working relationships.
• Lean Six Sigma Green or Black Belt.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
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. (ADA-United States of America)
