Regulatory Affairs Specialist

Job Role - Software As Medical devices SME

Location- Pune/Bangalore

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.

Mandate keyskills:

FDA Submissions

SAMD

510(k)

EUAI Act

ISO 13485 Auditors certification (external preferred)

Regulatory

Notice Period-Immediate to 30days