Regulatory and Quality

Job Role - Software As Medical devices SME

Location- Pune

Experience - 6 to 10 Years

• Bachelors 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.
• SAMD, SIMD IS MUST

Mandate keyskills:

• FDA Submissions
• SAMD
• 510(k)
• EUAI Act
• ISO 13485 Auditors certification (external preferred)
• Regulatory
• SUBHADEEP
• CTC :MAX 25 L