About UsWe are a fast-growing, innovation-led medical device startup committed to improving surgical outcomes and enhancing patient safety. As we scale across India and international markets, we are seeking a QARA Head (Quality Assurance & Regulatory Affairs) to establish and lead robust quality and regulatory systems, ensuring end-to-end compliance with global standards including ISO 13485, US FDA, EU MDR, and Indian CDSCO requirements.Your RoleBuild and lead our Quality Management System (QMS) from the ground up, aligning with ISO 13485, FDA 21 CFR 820, EU MDR, and CDSCO/MD5 regulations.Own the development and implementation of regulatory strategies for Indian and global markets.Lead internal and external audits, CAPA investigations, risk assessments, and management reviews.Oversee document control, validation, traceability, supplier qualification, and training systems.Collaborate with R&D, Manufacturing, Clinical, and Operations teams to integrate quality at every stage.Act as the primary liaison with regulatory authorities (e.g., CDSCO, Notified Bodies, FDA).Must HaveExperience working in start-ups or early-stage companies.Hands-on experience building a QMS from scratch.Minimum 5 years in QA/RA roles within the medical device or healthcare sector.In-depth knowledge of: ISO 13485 FDA QSR (21 CFR Part 820) EU MDRIndian regulations including CDSCO and MD5 LicenseProven experience with CAPA systems, audits, validation, and ISO 14971 risk management.Why Join Us?Play a leadership role in shaping regulatory and quality strategy at a high-impact startup.Drive innovations that directly improve surgical safety and patient care.Work with a passionate, interdisciplinary team and grow with the organization.
Job Title
QARA Head – Medical Devices