Regulatory Affairs Specialist

NMD Placement Consultancy; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

A leading recruitment firm seeks candidates for the role of Software as Medical Devices SME. Ideal candidates will have a bachelor's degree, 6 to 10 years of experience in a regulated industry, and strong knowledge of FDA Quality System Regulations. Responsibilities include drafting regulatory filings for Software as Medical Device and interacting with US and OUS Regulatory Authorities. Candidates with ISO 13485 Auditors certification are preferred.

Qualifications

• Bachelor's degree in relevant field or equivalent experience.
• 6-8 years working in a regulated industry.
• Experience with drafting regulatory filings.
• Experience drafting and submitting regulatory filings (Q-Submission, 510(k)).
• Filing for SaMD preferred; US FDA Class I/II devices experience required.
• Experience with US and international regulatory authorities and inspections.
• ISO 13485 Auditors certification preferred.

Skills

FDA Quality System Regulations

ISO 13485 Auditors certification

Regulatory filings experience

Medical device classification knowledge

Interaction with Regulatory Authorities

Education

Bachelor’s degree in relevant field

Tools

ISO 13485

Job description

Job Role - Software As Medical devices SME

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:

· ISO 13485 Auditors certification (external preferred)