MDR/Vigilance Manager
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Must Have: Minimum Requirements
Bachelor’s degree in health care, engineering or bioscience
field with 5+ years of medical device experience
Nice to Have
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)
- Experience in complaint management for medical devices and/or pharmaceuticals
- Knowledge and interpretation of MDR/complaint handling regulations
- Demonstrated track record of developing talent and managing people to reach their full potential
- Experience with FDA inspections and responses
- Demonstrated leadership and change management ability
- Process improvement mind-set
- Excellent communication (written and verbal) skills
- Experience in presenting to senior leadership
- Demonstrated strong analytical skills and appropriate use of clinical judgment
- Understanding and application of FDA adverse event reporting requirements
- Proficiency in Microsoft Windows, Excel, Power Point and Excel.
- Demonstrated team building and engagement results
- Demonstrated ability to multi-task and prioritize in a fast paced evolving environment
- Experience interpreting FDA regulations for 803 and 806, QSR, and ISO Standards.
- Experience interfacing directly with FDA contacts.
- Masters in Science or Business Administration or Regulatory Affairs
- Knowledge of Structural Heart products.
- Lean Sigma, CAP and Project Management Skills
- Demonstrated ability to develop and implement metrics and quality expectations
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)
