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Medical Compliance Manager for remote pandemic ventilator

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ArdenVent

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We are a non-profit organization building an infrastructure to develop, manufacture, distribute, and operate remote-controlled ventilators and oxygen concentrators that will also gather high-resolution treatment data for scientific research and treatment optimization.


Status report:
We are finishing off some design elements of the mechanical parts of our system and finalizing the first iteration of our software. We had several volunteers who meant to look into the regulatory aspects but they weren't able to keep up to their promises which is why this part of the project is currently dragging behind.

Description:
Since we plan to operate internationally we need a solid understanding of the most common medical regulations. Although the first iteration of the device should be considered a first-aid emergency device we are specifying it's functionalities for much more than that and ultimately would like to achieve ICU approval. Furthermore, there are not only mechanical safety regulations but we also must consider biometric data acquisition, data security, data privacy and software architecture regulations. As a result of this opportunity the equipment will be accepted much more readily among clinicians but we will also receive significantly more funding which will directly lead to many more lives protected.

Tasks:

  • assemble and lead a small team of volunteers to support you in the remaining tasks
  • research regulatory aspects in our initial target countries but also from the FDA
  • communicate the requirements with the developers
  • create documentation in conjunction with the developers to be handed to regulatory institutions
  • Approve and Quality Control documents handed to regulatory institutions
Training and/or experience required:
  • 1+ years homogeneous experience with medical regulatory compliance especially from the FDA
  • Ability to perceive technical details
  • International viewpoint and ability to research foreign compliance regulations.
  • Management and Leadership experience
  • Good Communication skills

If you feel you have the knowledge and skills necessary to assist with this position and you are interested in volunteering with us, please apply directly through our organization here: https://jira.ardenmed.com/plugins/servlet/loginfreeRedirMain?portalid=11&request=100

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About ArdenVent

Location:

Brigham Creek Rd 174, Hobsonville, Auckland 0618, NZ

Mission Statement

Our mission is to maximize the efficiency and effectiveness of the world's medical workforce fighting COVID-19

Description

We are a non-profit organization building an infrastructure to develop, manufacture, distribute and operate remote-controlled ventilators and oxygen concentrators that will also gather high-resolution treatment data for scientific research and treatment optimization.
Our equipment will be distributed on a "what you can pay" basis. Our Ventilator is different from other emergency Ventilators in that it will be controllable over the Internet, with the medical professional observing the patient over a phone camera, thus reducing viral load on the medical professionals at the front line, enabling those in stable countries to help and allowing one doctor to have an overview over many patients.

Our Ventilator is now in testing and we are finalizing fine air control. Parts cost for a single unit are 300$ but will drop in mass production and bulk ordering maybe even down to 200$.

Our roadmap consists of 4 Versions which can be deployed over the internet. It is envisaged that the Ventilator will be assembled by qualified volunteers, go through centralized quality control and then distributed to places of greatest needs on an international basis. Once enough funding is raised, a part of the workload will be outsourced to specialized companies.

Computers & Technology
Crisis Support
Health & Medicine

WHEN

We'll work with your schedule.

WHERE

This is a Virtual Opportunity, with no fixed address.

SKILLS

  • Software Engineering
  • System Engineering
  • Mechanical Engineering
  • Legal (General)
  • Contract Negotiations
  • Law Enforcement

GOOD FOR

N/A

REQUIREMENTS

  • 10h+ per week

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