Senior Program Manager, Compliance
- Bachelor's degree with 7+ years experience working with the FDA or in quality and/or quality systems experience in the medical device industry or Master's degree with a minimum of 5+ years experience working with the FDA or in quality and/or quality systems experience in the medical device industry.
- A deep technical understanding of medical device and combination product compliance to FDA regulations.
- Hands on experience dealing with large-scale non-compliant organizations with a track record for turning around the organization to compliant outcomes in inspections and beyond.
- A solid understanding of how people journey through a change and the change process; Experience and knowledge of change management principles, methodologies and tools
- Demonstrated capacity for strategic thinking, project planning and project management.
- Strong communication, organizational, presentation and leadership skills are desirable. Good communicator and fluent in English, both in writing and speaking.
- Excellent analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions.
- Excellent organizational and time management skills.
- Successful track record of leading projects through implementation.
- Strong computer skills, including MS Office Suite and database and project management software.
- Requires the ability to negotiate and manage competing priorities across multiple functional areas.
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)