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3 people are interested
Regulatory Affairs Specialist
ORGANIZATION: ArdenMed
Please visit the new page to apply.
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3 people are interested
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.
We are looking for an experienced Regulatory Affairs Specialist. This will be an exciting and diverse regulatory aspects as it will involve coordinating or liason with cross boarded organizations and Government. This is all at an international level medical professionals and administration all making contributions to this project followed by conversion of prototypes into production designs and production itself.
Prior experience with JIRAand Confluence is a plus.
Job description:
- Compile and prepare regulatory documents for submission to regulatory agencies more specifically Asian countries ( India, Pakistan, Nepal)
- Good to have knowledge on submission with Asia specific countries such as India, Pakistan, Nepal
-Following up when required and updating the relevant manager
There is no total time requirement, but it is expected that the Regulatory Specialist will keep the information flow so as information is made available in a timely way. The Regulatory Specialist will be aware how critical this information is for such a complex and extensive project.
This opportunity is only available to those who have had experience or have had extensive studies and are willing to make up the difference of their lack of experience with a solid effort. Experience with good communication would be a considerable asset.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
More opportunities with ArdenMed
3 ReviewsNo additional volunteer opportunities at this time.
About ArdenMed
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
Every Year 4.2 million children under 5 are desperate for oxygen. 800,000 mothers lose their child every year because of Pneumonia, a lung disease often requiring oxygen. This toll is higher than for any other disease in the world. What hospitals in the US and Europe consider one of the most essential treatments is not available for many. The problem, oxygen concentrators keep breaking down in the high humidity, temperature and dust environments, burn through during energy spikes when the power comes back online after one of the many outages or simply breaks and nobody knows how to repair it.
We have set out to change this and develop an oxygen concentrator that will make public health investments much more effective. Our first calculations suggest that we could lower the cost of a child's life by as much as two-thirds. Due to our organization working with volunteers we can reduce the development cost but bringing a medical device to market is hard work and we expect that you meet the requirements and are responsive and transparent with your skills and availability. If our mission sounds important and exciting to you, learn more about us on www.ardenmed.com and apply for one of our open positions through our platform! http://jira.ardenmed.com/plugins/servlet/loginfreeRedirMain?portalid=16&request=136
CAUSE AREAS
WHEN
WHERE
This is a Virtual Opportunity with no fixed address.
DATE POSTED
April 20, 2021
SKILLS
- Executive Admin
- Administrative Support
- Group Facilitation
- Management
- Research
GOOD FOR
N/A
REQUIREMENTS
N/A