SAMD Specialist

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About the Role

Job Role - SAMD (Software As Medical devices)

Location- Bangalore/Pune/Hyderabad/Chennai

Responsibilities

• 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 experience with FDA Class III devices and OUS device classification a plus.
• Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections.

Qualifications

• Mandate keyskills: FDA Submissions
• 510(k)
• EUAI Act
• ISO 13485 Auditors certification (external preferred)
• Supplier Quality