SAMD Specialist

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Job Role - Software As Medical devices SME

Location- Pune

Experience - 6 to 10 Years

• Bachelor’s degree in relevant field (or equivalent experience)
• 6 - 8 years working in a regulated industry (FDA and Software as a Medical Device preferred).
• Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
• Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, and Traditional and Special 510(k) filings. Filings for Software as Medical Device preferred.
• Experience with US FDA Class I and II medical devices. Additional ...