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Sr Regulatory Affairs Director, US

Regulatory Affairs
200006WS Requisition #
Careers that Change Lives:

As the Senior Regulatory Affairs Director, you’ll be the Regulatory Strategist for the United States region and will focus on stakeholder engagement and partner closely with the Medtronic Diabetes Group Sr Staff, the Innovation organization and the Americas Commercial leader. You will build effective regulatory relationships with the FDA.

A Day in the Life:


Your responsibilities may include the following, and other duties may be assigned:

  • Develop and lead strategies that provide a competitive advantage in the market in addition to the earliest possible approvals of new product development
  • Establishes organization goals and objectives and leads regulatory personnel. Champions engagement, inclusion and diversity efforts as well as career development and performance management
  • Partners with innovation leaders to support execution of regulatory strategy, provides guidance and ensures compliance with regulatory requirement
  • Develop and execute OEM (original equipment manufacturing) strategies. Partner with OEMs and build effective relationships to ensure safety and effectiveness of these entities’ products and services
  • Partners directly with health economics, reimbursement and government affairs to influence regulations globally, but specifically within the United States in order to provide the best product position/ price for our patients
  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
  • Leads or compiles all materials required in submissions, license renewal and annual registrations
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
  • Monitors and improves tracking/ control systems in coordination with Regulatory Operations
  • Support new venture initiatives
  • Keeps abreast of regulatory procedures and changes

Must Have: Minimum Requirements:
  • Bachelor’s degree
  • Medical device or highly regulated industry experience
  • 15+ years of relevant experience with 10+ years of managerial experience or Advanced Degree with a minimum 13 years relevant experience and a minimum of 10 years of managerial experience

Nice to Have: Preferred Requirements:

  • Broad regulatory experiences in both pre- and post- market
  • 13+ years of 510K, PMA experience
  • Software/ digital health experience including Artificial Intelligence (AI), Machine Learning (ML)
  • Standards Council, industry lobbying exposure/ experience

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)

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

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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.


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