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Principal Regulatory Affairs Specialist - CSF

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Regulatory Affairs
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20000JLW Requisition #

PRINCIPAL REGULATORY AFFAIRS SPECIALIST - CSF


This position is part of the CSF Team. CSF-Flow Control valves are fixed pressure valves. They’re part of a shunt system used to treat the symptoms of hydrocephalus. A shunt redirects excess cerebrospinal fluid (CSF) in the brain to another part of the body, allowing the brain’s enlarged ventricles to return to a more normal size.


Careers that Change Lives


The Principal Regulatory Affairs Specialist - CSF 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.

A Day in the Life
  • Provide leadership on project teams, providing regulatory strategy, timelines, and deliverables
  • Prepare US and EU submissions.  Work with FDA, Notified Body, and regulatory geography support to obtain product approval/clearance.
  • Develop US and International regulatory strategies and timelines for product submissions; identifying needs for bench, animal and clinical testing
  • Review Change Orders and assess regulatory impact of product changes on US, EU and/or International regulatory strategy and submissions per standard procedures
  • Review labeling and assess compliance against relevant regulations and product requirements
  • Develop and maintain regulatory affairs department procedures and process improvements
  • Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct
  • Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
  • Provide mentorship, training and support to other members of the department
  • Assist in keeping company informed of regulatory requirements in the US and EU.
  • Other tasks, as assigned.
 Must Have: Minimum Requirements
  • Bachelor's Degree required.  Engineering or Advanced degree desired.
  • 7+ years of US/EU medical device regulatory affairs experience with Bachelor’s degree   - OR -
  • 5+ years of US/EU medical device regulatory affairs experience with an advanced degree

Nice To Have

  • Degrees in Engineering or Regulatory Affairs preferred
  • Expertise in 510(k)s, EU MDR Technical Documentation
  • Knowledge of FDA and EU requirements
  • Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for medical devices (510(k)), Investigational Device Exemption (IDE), EU MDR, medical device submissions)
  • Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
  • Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations
  • Regulatory Affairs Certification (RAC)
  • Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting
  • Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
  • Ability to compile data and summarize results
  • Organized, efficient, process-oriented; high attention to detail
  • Effective interpersonal/communication skills
  • Works well under pressure in a dynamic timeline-driven environment
  • 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)
 

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

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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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