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Regulatory Affairs
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20000FT6 Requisition #
PRINCIPAL REGULATORY AFFAIRS SPECIALIST

The Restorative Therapies Group (RTG) develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
 
BRAIN THERAPIES offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, strokes and aneurysms, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.
Medtronic’s Neurovascular Team in Irvine, CA plays a vital role in improving stroke awareness, prevention and treatment.
Our efforts will have lasting impact on countless individuals and families — it is an opportunity we value and take pride in.
Medtronic Neurovascular is focused on creating life-saving devices to treat stroke. As part of the Brain Therapies Organization, we are revolutionizing how acute ischemic and hemorrhagic stroke is treated all over the world. We are focused on meeting our goal of no patient lost, no patient delayed, best patient outcome


Careers that Change Lives

 

The Principal Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe.  This position is also responsible for the regulatory global strategy, review of design changes, manufacturing changes and specification changes. The Principal RAS clearly communicates strategies to Regulatory Affairs (RA) management, project teams, and business unit leadership.  You will prepare regulatory filings for new products, as well as post market changes. As necessary, you will also review complex regulatory issues with RA management.

 

A Day in the Life

  • Lead business critical new product development projects and provide regulatory oversight to maintain lifecycle ensuring that the State of the Art requirements are maintained.

  • Identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to project teams and RA management. 

  • Provide leadership to business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for changes to existing products.

  • Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

  • Lead preparation of FDA submissions and CE Mark Technical Files (MDD and MDR) for product changes and/or new products as required to ensure timely approvals for market released products.

  • Develop US and EU regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.

  • Assist in keeping company informed of regulatory requirements in the US and EU.

  • Participate on Product Development teams by providing regulatory strategy, timelines, and direction.

  • Prepare US and EU submissions.  Work with Notified Body and FDA to obtain product approval/clearance. Ensure relevant ISO and FDA requirements are met, as required.

  • Review Change Orders and assess regulatory impact of product changes on US and/or EU regulatory strategy and submissions per standard procedures.

  • Review labeling, training, promotional and advertising material.

  • Support post market regulatory compliance activities for US/EU product approvals.

  • Develop and maintain regulatory affairs department procedures and process improvements

  • Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct

  • Keep company informed of regulatory requirements in the US and EU.


Must Have: Minimum Requirements (Must be evident on the resume)
 
• Bachelor's Degree required. 
• 7+ years of US/EU medical device regulatory experience with Bachelor’s degree or an advanced degree and minimum 5 years medical device regulatory experience

Preferred Qualifications:

• 510(k) or PMA submission experience
• Engineering or Advanced degree preferred
• Knowledge of FDA and EU requirements
• Degree in Engineering, Science, or Regulatory Affairs
• Strong communication skills
• Strong technical writing skills
• Regulatory Affairs Certification
• Master’s degree in Regulatory Affairs or Engineering
• PMA experience
• IDE 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 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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