Policy Analyst

by | Oct 17, 2020 | Careers | 0 comments

The Company

The Ventilator Project is a new non-profit startup located at MassRobotics in the Seaport district of Boston. Our mission to construct a low-cost, universally accessible ventilator that can save the lives of Covid-19 patients experiencing respiratory illnesses worldwide. Current ventilators can cost upwards of $40,000. Our goal is to rapidly prototype, build & ship ventilators built from readily available parts for a fraction of this price, providing hospitals & patients with a cheaper alternative. Everyone deserves a chance to fight COVID19, fight with us.

DISCLOSURE: Current on-site volunteers are working in an isolated office setting while practicing safe social distancing practices. We have gloves and masks readily available, and the office space is professionally cleaned several times throughout the week.

Job Summary

The Ventilator Project is looking for a FDA Policy Analyst who will be responsible for providing policy guidance to the engineering and manufacturing teams. This individual will be learning as well as acting as the policy liaison on the FDA EUA and 510k submission process, FMEA risk analysis, quality management system (QMS), and FDA labeling. The policy analyst will also be collaborating with associate attorneys, law firm partners, and former white house officials on behalf of The Ventilator Project.

Required Skills

  • Pursuing or hold a bachelor’s degree.
  • Confident ability to distinguish nuances in legal documents and read efficiently through dense policy materials
  • Experience crafting analytical documents, memos, and draft revisions of research or policy related work.
  • Experience in business administration and project management can be helpful.
  • This position is on-site only. Flexibility to work part-time as well as remotely, but expected to be on-site at minimum a few times a week.

Ideal Skills:

  • JD, MBA, and MPP/MPAs are encouraged to apply.
  • Experience speaking with high-level government officials and/or attorneys

Please apply here: https://k7y.pl/s/gleDn