We are looking for a senior level regulatory and quality affairs generalist who has successfully cleared FDA medical devices and has seen first hand the pitfalls and delays caused by outdated mindsets and processes.

You’ll split your time between managing our own company RA/QA, supporting our customers with their projects, and providing our engineering and product teams with input on how to build the best compliant products out there.

You might lean more towards the R or the Q side but, either way you have 5-10 years experience with RA/QA associated with medical device development (combinations products also a plus). You have experience high tech (read: devices with software/electronics) devices and the unique challenges that go along with their development. You’ve written quality documents (SOPs, WIs, templates etc.) from scratch and know and follow industry best practices when appropriate. That being said, you are also are open to new ways of looking at regulatory and quality activities and aren’t shy about challenging the old ways of thinking, as long as the new way is still compliant.

You are comfortable taking a Class I and II (and maybe III) device through the approval process and may have experience with international regulations. You have worked closely with engineering teams and know how to deal with the unique challenges arise when trying to get engineers to do “regulatory and quality stuff.”

You have working knowledge of most of these buzzwords, and are probably an expert in a handful of them:

  • 21CFR pt 820 / ISO 13485
  • 21CFR pt 11
  • CE Mark
  • Design & Document Control
  • ISO 14971 Risk Management
  • Software Development for Medical Devices per IEC 62304
  • Human Factors Engineering per ISO 62366
  • 60601 and its collateral standards
  • Pre-Submission meetings and 510(k) applications
  • Pre-IND meetings and 505b(2) applications