Principal Regulatory Affairs Specialist (remote)

Must Have (Minimum Requirements):

•  Bachelor’s degree
• Minimum 7 years experience in regulatory affairs or the medical device industry, 
• Or advanced degree and a minimum of 5 years of experience in regulatory affairs, or the medical device industry.

Nice To Have (Preferred Qualifications):

• Degree in engineering
• 9+ years medical device industry experience
• Experience working with medical device or pharmaceutical regulatory submissions
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
• Effective interpersonal skills
• Effective team member
• Ability to comprehend principles of engineering, physiology and medical device use. 
• Good analytical thinking skills.
• Ability to effectively manage multiple projects and priorities.
• Proficient computer skills 
• Experience with Class II/III medical devices (510(k), PMA, IDE)
• Experience performing advertising and promotion reviews for medical devices
• Medtronic product development experience
• Clinical or statistical experience
• Experience with FDA and international regulatory agency requirements, ISOIGHTF standards
• Project management skills

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.