Medical Device Regulatory Professional

1 week ago


Irvine, California, United States Elevate Search Full time

Job Summary:

Elevate Search is partnering with a leading medical device company to find a Regulatory Affairs Project Manager. This individual will report to the Director of Regulatory Affairs and play a critical role in the FDA approval process of a groundbreaking implantable device.

Key Responsibilities:

  • Engage in regular meetings with the FDA to ensure compliance with regulatory requirements
  • Participate in clinical trials and provide regulatory expertise
  • Collaborate closely with the leadership team to drive the PMA application process
  • Develop and implement regulatory strategies to ensure compliance with US regulations
  • Provide guidance on regulatory matters to cross-functional teams

Requirements:

  • Bachelor's degree in a scientific discipline
  • Prior US experience in regulatory affairs
  • Proven experience with PMA applications
  • At least 5 years of experience in regulatory affairs
  • Willingness to work onsite in Irvine at least 3 days a week

What We Offer:

  • Exceptional benefits package, including medical, dental, and vision insurance
  • 401K match and annual bonus
  • PTO and 13 paid holidays
  • A transparent and visible leadership team


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