🌎
This job posting isn't available in all website languages

Regulatory Affairs Specialist - Pre Market

📁
Regulatory Affairs
📅
190003A6 Requisition #
Thanks for your interest in the Regulatory Affairs Specialist - Pre Market position. Unfortunately this position has been closed but you can search our 2,281 open jobs by clicking here.
Must Have; Minimum Requirements
  • Bachelor’s degree with 2+ years of regulatory or clinical experience or Master’s degree with 0 years of regulatory or clinical experience
  • Experience in healthcare industry (i.e. medical device, pharma/drugs, biologics, biotech)
Nice To Have
  • Master’s Degree or Doctorate in Regulatory Affairs, Engineering, Quality or related technical field
  • Experience in preparing regulatory submissions (i.e. Premarket Approval (PMA) for Class II and/or Class III medical devices and technical files or design dossiers)
  • Experience with regulatory support of clinical trials
  • Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting
  • Organized, efficient, process-oriented; high attention to detail
  • Effective interpersonal/communication skills
  • Ability to effectively manage multiple projects and priorities
  • Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software 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)

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions
Please try again.

Oops!

Either there was a problem on our end with the action you just performed, or we are currently having technical difficulties with our system. Please try again later.

Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

Learn More

Sales

Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

Learn More

Regulatory

Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

Learn More

Read About The
Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

Learn More

EMPLOYEE STORY:
ENGINEERING

Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

Learn More

WONDERING ABOUT
WORKING AT
MEDTRONIC?

Our employees come from varied backgrounds with a common goal—changing lives.

Learn More

We value what
makes you
unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

Learn More
The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

WORKING AT
MEDTRONIC

Be part of one of the world’s leading medical technologies and solutions companies.