Job Title: QARA Lead Experience: 3–6 years Location: Bengaluru, India (IISc Campus) Responsibility : Quality Management System: Architect, implement, and maintain a lean, audit-ready ISO 13485:2016 Quality Management System (QMS). Drive certification and act as Management Representative (MR) for audits and regulatory inspections. Regulatory Strategy & Submissions: Define and execute regulatory strategies for CDSCO (Class II/III), FDA 510(k), and EU MDR CE Mark. Prepare, review, and submit regulatory dossiers; interact with authorities and notified bodies. Design Control & Documentation: Own all design-control documentation (SRS, DHF, Risk Management File, DMR, Technical File, etc.) in collaboration with engineering teams. Translate regulatory requirements into actionable tasks for engineers. Compliance & Standards: Ensure compliance with ISO 13485, ISO 14971, IEC 60601, IEC 62304, and Indian MDR 2017. Maintain strong exposure to IEC 60601 and other applicable standards for Class C active medical devices. Internal Audits & CAPA: Plan and conduct internal audits, manage CAPA investigations, and lead continuous-improvement initiatives. Supplier & Manufacturing Oversight: Qualify and monitor suppliers/CMOs; establish incoming/in-process quality controls and batch-release records. Support or lead the process for obtaining CDSCO manufacturing licenses. Training & Change Control: Train cross-functional teams on standards, good documentation practices, and change-control procedures. Post-Market Surveillance: Set up post-market surveillance, complaint handling, and vigilance procedures ahead of product launch. Requirment : Education: Bachelor’s degree in Engineering (preferably Biomedical), Life Sciences, or related field. ISO 13485 internal-auditor certification preferred. Experience: 4–6 years of QARA experience with Class II or higher medical devices, ideally in a startup or small-team environment. Hands-on experience with Class C active medical devices. Technical Skills: Demonstrated implementation of ISO 13485 QMS, compilation of CDSCO dossiers, and/or FDA/CE submissions. Strong understanding of technical specifications, schematics, test protocols, and engineering terminology. Regulatory Knowledge: Working knowledge of ISO 14971, IEC 60601, IEC 62304, Indian MDR 2017, EU MDR, and FDA 510(k) processes. Other Skills: Excellent documentation skills, analytical mindset, and ability to work independently in a fast-paced startup environment. Strong communication and training abilities. Show more Show less