Regulatory Affairs Manager - International

Must Have; Minimum Requirements 

• Bachelor's Degree required.  Engineering or Advanced degree desired.
• Minimium 5 years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility
• Or a minimum of 3 years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility

Nice To Have

• 2+ years of leadership experience as demonstrated through direct management and/or mentorship/advisory capacity
• Experience managing a Regulatory Affairs international function
• Excellent knowledge of European/International regulations and standards
• 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
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
• Experience reviewing design specifications and other technical documents
• Interpret new and changing international regulatory requirements, communicate impact to stakeholders, and support development of implementation plans
• Excellent interpersonal and communication skills, both oral and written
• Documented evidence of writing skills
• Working understanding of computer applications; proficient in Microsoft Office Applications
• Familiarity with medical terminology
• Some overnight travel required

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.