Job Description

Job Description Summary

Job Description

P3-14314

Job Responsibilities

  • Represents Regulatory Affairs on product development teams to support new product development and change control to ensure US, EU, and other global regulatory requirements are met
  • Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market
  • Reviews and approves design control documentation and product labeling in consideration of US, EU, and other global regulatory requirements
  • Authors FDA submissions, EU technical files, and other regulatory documents for submission to regulatory bodies for product review and approval
  • Leads interactions with FDA, EU notified bodies, and other regulatory agencies on submissions and other issues
  • Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mar...

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