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Regulatory Affairs Specialist

Company: Medtronic
Location: Irvine
Posted on: November 18, 2021

Job Description:


This position is part of the Cerebrospinal Fluid (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.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident -we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Careers That Change Lives

The Regulatory Affairs Specialist supports planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe. This position will support the regulatory global strategy, review of design changes, manufacturing changes and specification changes.

A Day In The Life

  • Participate 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 (Must be evident on the resume)
    • Bachelor's Degree required.
    • Minimum 2 years of US/EU medical device regulatory experience with Bachelor's degree - OR -
    • Minimum 0 years of US/EU medical device regulatory experience with advanced degree
      Nice To Have
      • Advanced degree in Regulatory Affairs
      • 510(k) or PMA submission experience
      • Degrees in Engineering or Regulatory Affairs preferred
      • Knowledge of FDA and EU requirements
      • Regulatory Affairs Certification
      • Strong negotiation skills and written/oral communication skills
      • Strong technical writing skills
      • Strong organizational skills and time management 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)

        Additional Information
        • Posting Date: Oct 26, 2021
        • Travel: No

Keywords: Medtronic, Irvine , Regulatory Affairs Specialist, Other , Irvine, California

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