Hi, I'm looking for a project manager to assist in manage various small departments &amp; projects in the Software Development Lifecycle (SDLC) of our first medical software. &nbsp;We are a small startup company with a team of roughly 10, mostly of whom are working part-time. &nbsp;We are currently developing a product that must meet regulatory requirements of the United States and Europe.
It would be highly advantageous if you have prior experience with ISO 13485, IEC 62304, CFR 820, CFR 21 part 11, and other regulations relating to FDA &amp; MDR. &nbsp;We are not looking for an auditor. &nbsp;Instead, we are looking for a project manager to create employee specific tasks, create Gantt charts, project timelines, &nbsp;and track deliverables to ensure timelines are met.
Initially, you will undergo training, receive product documents for review, and we will set up a series of calls to further your understanding of our company, product, and goals to better patient outcomes.
The ideal candidate will have experience with software development, familiarity with applicable regulations, and will be able to interface across departments seamlessly. &nbsp;We are looking for somebody that is hyper-organized and detail oriented.
If you have read this job description, please include the first 4 numbers of pi in your application.
Pricing, timelines, and additional information will be elaborated on. &nbsp;We are looking for a medium term contract that will evolve into long-term work.&nbsp;
Thank you and I look forward to hearing from you.
-David

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Project Manager for Software as a Medical Device Development

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