MDR/Vigilance Manager
Careers That Change Lives
A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.
In this exciting role as a MDR/Vigilance Manager you will have responsibility for the complaint handling function of the Pelvic Health Operating Unit with the Enterprise Customer Quality Organization.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- 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.
- Lead Continuous Improvement initiatives and strategic initiatives in partnership with the Operating Unit and the Customer Quality function to improve outcomes for our internal customers and our patients.
- Lead a team of complaint handlers to achieve above outcomes.
- Travel requirement:
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering, Quality, and/or experience in a regulated industry OR Advanced Degree in Engineering, Science or technical field with 3+ years of work experience in Engineering, Quality, and/or experience in a regulated industry.
Nice to Have
- 2+ years of people leadership in a fast paced, regulated environment.
- Demonstrated track record of developing talent and managing people to reach their full potential
- Demonstrated leadership and change management ability
- Process improvement mind-set
- Experience in presenting to senior leadership
- Demonstrated team building and engagement results
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)
