Sr. Regulatory Affairs Specialist

1 week ago

Irvine, United States Redbock - an NES Fircroft company Full time

Senior Regulatory Affairs Specialist will beresponsible for implementing regulatory strategies, assisting with the preparation, organization, and maintenance of documentation sufficient to ensure regulatory compliance of all new and existing products. In this role, you will prepare product submissions, handle license renewals, and provide periodic updates and registrations to regulatory agencies. This job works hybrid out of Irvine, CA.

You will:

  • Represent Regulatory Affairs on R&D product development teams to ensure all regulatory requirements are communicated and met throughout the product development process
  • Provide insight into regulatory standards products must meet, test method requirements, and the body of evidence required for US and OUS regulatory submissions
  • Complete submissions to FDA, EU, and other regulatory agencies
  • Actively participate in the evaluation for regulatory compliance of documents, products, and processes and test methods
  • Review labeling and labels for compliance to regulatory standards and to regulatory submissions
  • Provide regulatory reviews of customer complaints, define regulatory reportability, and complete reports as required
  • Prepare periodic risk assessment and post market surveillance summary documentation
  • Prepare input data to periodic clinical evaluation reports
  • Prepare materials for license renewals, updates, and registrations in a timely manner

You need:

  • Bachelor degree and 4+ years in medical device regulatory affairs
  • Understanding of current FDA and International regulations, guidance and standards applicable to medical device products
  • Excellent written and verbal communication skills
  • Be able to be onsite a minimum 3 days per week in Irvine, CA
  • Orthopedic device experience preferred

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