Dear RAPS Community,
I am searching for a remote role QA/RA role in the medical device, combination products, and SaMD. I have more than 10 years of experience in implementing Quality Management System for Class II and III medical devices. I have submitted multiple 510(K)s and technical files. Recent achievements:
-Implemented QMS for SaMD
-MDSAP- Implemented country-specific requirements, hosted audit--outcome--achieved MDSAP certificate for SaMD organization
-Gap Analysis of QMS, Technical file to MDR (2017/745), and updates to QMS Procedures and Technical file
Please let me know if anyone is looking to fill a remote role.
Thanks,
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Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
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