Regulatory Affairs Specialist

Job Role - Software As Medical devices SME

Location- Pune/Bangalore

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.

Mandate keyskills:

· FDA Submissions

· SAMD

· 510(k)

· EUAI Act

· ISO 13485 Auditors certification (external preferred)

· Regulatory

Notice Period-Immediate to 30days