Principal Regulatory Affairs Specialist - Neuromodulation

Must Have; Minimum Requirements 

 

• Bachelors degree required
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
• Or minimum  5 years of medical device regulatory affairs experience with Master’s degree

 Nice To Have

• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical skills
• 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, US and major market regulatory requirements, project management, and negotiations
• Regulatory experience with higher risk classifications (US Class III)
• 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
• Excellent interpersonal and communication skills, both oral and written
• Working understanding of computer applications; proficient in Microsoft Office Applications
• Minimal 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)