This job posting isn't available in all website languages

Principal Regulatory Affairs Specialist

Regulatory Affairs
21000DW4 Requisition #
Thanks for your interest in the Principal Regulatory Affairs Specialist position. Unfortunately this position has been closed but you can search our 3,102 open jobs by clicking here.

Must Have (Minimum Requirements):

  • Bachelor’s Degree required with a minimum of 7 years of regulatory affaris experience in the medical device industry, or advanced degree with a minimum  of 5 years of regulatory affairs experience in the medical device industry.  

Nice to Have (Preferred Qualifications):

  • 7+ years of regulatory submission experience
  • Excellent writer
  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
  • Experience with PMA, IDE, De Novo, and/or 510(k) product and submissions.  PMA experience desired.  
  • Experience in supporting Class III device or IIb active medical device European Technical documentation and Submissions.
  • Highly proficient in spoken and written English.
  • Experience with negotiations/interactions with regulatory agencies/health authorities is preferred.
  • Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
  • Ability to effectively manage multiple projects and priorities 
  • Proven ability to lead and work effectively in cross-functional teams
  • Strong organization and time management skills
  • Demonstrated ability to influence based on experience, facts and data
  • Project-management skills and experience
  • Presentation skills for small to mid-sized groups
  • Submission-related word processing skills
  • Experience working within a medical device Quality System 


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)

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

Rice Creek, Minnesota, United States

📁 Regulatory Affairs

Requisition #: 21000F9U

Rice Creek, Minnesota, United States

📁 Regulatory Affairs

Requisition #: 21000HRL

Rice Creek, Minnesota, United States

📁 Regulatory Affairs

Requisition #: 21000DW8


FORTUNE puts Medtronic among the top 20 companies worldwide having a positive social impact through core business strategy.

Read The Story


Bring your talents to help us build life-changing technology


Three Women Working


We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.