Codvo AI - Compliance Subject Matter Expert

Job Description : Compliance SME Medical Device Software

Department : Regulatory & Quality Assurance

Role Overview :

We are seeking a highly skilled and detail-oriented Compliance Subject Matter Expert (SME) to lead and support regulatory compliance initiatives for medical device software.

The ideal candidate will have deep expertise in global regulatory frameworks, quality management systems, and risk management practices applicable to software as a medical device (SaMD).

Key Strategy & Engagement :

• Lead classification and regulatory pathway analysis for SaMD under FDA guidelines, including 510(k) submissions.
• Facilitate early engagement with FDA through pre-submission meetings.

Quality Management System (QMS) :

Software Lifecycle Compliance :

Risk Management :

Required Qualifications :

Preferred Qualifications :

What We Offer :

(ref : iimjobs.com)