Role & responsibilities:
Independently manage and prepare US FDA Medical Device Regulatory submissions. •Prepare, review, and submit 510(k) Premarket Notification applications for medical devices.

•Handle FDA Device Listing and Establishment Registration processes.

•Prepare regulatory strategies for De Novo Classification Requests.

•Manage submissions through the FDA eSTAR Portal.

•Perform regulatory assessment of medical devices including:

oDevice classification oPredicate device identification oSubstantial equivalence evaluation oRegulatory pathway determination

•Review and prepare technical documentation required for FDA submissions,

including:

oDevice description oIntended use and indications for use oPerformance testing requirements oLabeling requirements oRisk management documentation





•Provide guidance regarding FDA Quality System Regulations (21 CFR Part 820)

compliance.

•Support clients in establishing and maintaining medical device QMS requirements.

•Review Quality Management System documentation, including:

oQuality Manual

oSOPs oDesign Controls oCAPA oComplaint Handling oDocument Control oProduction & Process Controls •Stay updated with changes in:

oUS FDA Medical Device Regulations o21 CFR Part 820 requirements oFDA guidance documents oeSTAR submission requirements

•Coordinate with international clients, manufacturers, and internal regulatory teams.

📌 Us Fda Regulatory Affairs Specialist New Delhi (India)
🏢 ELT Corporate
📍 India