Medical Compliance Manager for remote pandemic ventilator

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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.

This is a great opportunity for somebody who wants to work with a dedicated team of engineers and providers to create groundbreaking technology. You have the opportunity to directly impact the quality and safety of this technology by following mostly simple (but long) instructions from regulatory bodies such as the FDA. You will get the chance to become highly qualified in the design and development process of medical devices which can be directly applied to the process in any other industry except for the much greater clarity to be gained in this field. For any engineer, experience with this level of process control and coordination is a highly valuable experience for your CV.

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 have made a reasonable start with documenting our design and implementing the required document, quality and design control for medical approval and acquired tools that will support and automate the process. However, a lot still needs to be done

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 in a future iteration 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

• 5+ years of work experience
• Experience with industrial design control or medical regulatory compliance ideally with the FDA
• Ability to perceive technical details
• International viewpoint and ability to research foreign compliance regulations.
• Management and Leadership experience
• Good Communication skills

Become part of our mission by filling out our application form at http://jira.ardenmed.com/plugins/servlet/loginfreeRedirMain?portalid=16&request=136

That others may breathe!

Become part of our mission by filling out our application form at http://jira.ardenmed.com/plugins/servlet/loginfreeRedirMain?portalid=16&request=136

That others may breathe!