Senior Regulatory Affairs Manager - Surgical Robotics
Must Have; Minimum Requirements
- Bachelor's Degree
- Minimum 7 years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility
- Or an advanced degree with minimum 5 years of experience in regulatory affairs in the medical device industry
- Minimum 5 years of leadership experience as demonstrated through direct management and/or mentorship/advisory capacity
Nice To Have
- Engineering or Advanced degree desired.
- Extensive experience at formulating successful regulatory strategies that meet established approval timelines, while maintaining the highest level of quality
- Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, WW Regulatory Requirements/Procedures, Project Management, Negotiations, Medtronic Product/Design/ Development Systems
- Regulatory experience with higher risk classifications (US Class II/III)
- Ability to recognize and develop key talent
- Experience interacting with regulatory agencies
- Proven ability to prioritize, conduct, and manage time to meet project deadlines
- Demonstrated ability to work well in dynamic and cross functional team environments
- Demonstrated collaboration and leadership skills in team setting including ability to coach and develop team members, and effective resource management to address multiple priorities
- Solid understanding of manufacturing and change control, and an awareness of regulatory trends
- Experience reviewing design specifications and other technical documents
- Excellent interpersonal and communication skills, both oral and written
- Working understanding of computer applications; proficient in Microsoft Office Applications
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)
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.
Learn more about our benefits: benefits.medtronic.com
This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here.