Principal Regulatory Affairs


Junto HLS is working directly with Regulatory Leadership at a leading medical device company on a Principal Regulatory Affairs Associate position.

Select Accountabilities:

  • Develop strategies for submissions to FDA and other regulatory agencies
  • May provide leadership and direction to assigned regulatory staff
  • Prepare FDA submissions necessary for new product approvals/clearances: Premarket notifications – 510(k)s, Premarket Approval Applications (PMAs) and supplements and Investigational Device Exemptions (IDE) submissions
  • Responsible for the preparation of Regulatory Assessments and Notes to File for assigned projects
  • Coordinate preparation of additional information and data requested by regulatory agencies and prepare appropriate responses to such requests
  • Responsible for the day-to day oversight and management of assigned projects
  • Independently review and approve relevant documents, including engineering changes, advertising and promotional materials and product development reports
  • Develop and maintain regulatory procedures and policies to ensure ongoing compliance of existing and new products


  • Greater Boston, MA

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