Remote Regulatory Affairs Bardy Diagnostics Manager

This job has been removed
Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Fri, Aug 05, 2022
This job expires in: 20 days
Job Summary

A medical device manufacturing company is filling a position for a Remote Regulatory Affairs Bardy Diagnostics Manager.

Core Responsibilities Include:

  • Supporting product development and sustaining engineering projects
  • Developing/advising company on regulatory strategies for new medical device products
  • Preparing regulatory documentation and manage pre-market submissions to relevant authorities

Must meet the following requirements for consideration:

  • Minimum of seven plus years of progressive experience in medical device regulatory affairs
  • Bachelor’s degree or equivalent
  • Successful preparation and submission of 510(k)s and/or international documents and registrations
  • Strong working knowledge of US and international medical device regulations and standards
  • Experience with developmental best practices for medical device hardware and software
  • Ability to work independently and as part of team, strong collaborative skills
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