fbpx

Policy Analyst

by | Jan 14, 2021 | Careers | 0 comments

All opportunities with TVP Health are currently unpaid volunteer positions that will give you a rich and unique opportunity to learn and participate alongside highly regarded industry experts.

The Company

TVP Health is a 501c3 nonprofit located at MassRobotics in the Seaport district of Boston. Our mission to simplify complex biomedical products to make them accessible and affordable for all. Our first ventilator, AIRA, was developed to be a universally accessible ventilator that could 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. As of March 2021, our AIRA ventilator acquired the FDA EUA (Emergency Use Authorization).

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 holding a bachelor’s degree in a scientific or related discipline.
  • Confident ability to distinguish nuances in legal documents and read efficiently through dense policy materials.
  • Experience in analyzing and synthesizing scientific or technical documentation.
  • Experience crafting analytical reports, memos, and draft revisions of research or policy related work.
  • Experience in business administration and project management can be helpful.
  • Experience in analyzing and synthesizing scientific or technical documentation.
  • This position is remote or on-site and unpaid/volunteer. Analysts are expected to work a minimum of 4 days per week, ~3 hours per day.

Ideal Skills

  • JD, MBA, and MPP/MPAs are encouraged to apply.
  • Experience speaking with high-level government officials and/or attorneys
  • Background in engineering discipline.
  • Understanding of the medical device industry and development process.

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