? We're Hiring | QARA Lead – Medical Devices ?

Location:
Bengaluru, India (IISc Campus) ?

Experience:
5–7 Years We are looking for an experienced Quality Assurance & Regulatory Affairs (QARA) Lead to drive quality management systems, regulatory compliance, and product certification for innovative medical devices. ?

Key Responsibilities
• Establish and implement an end-to-end QMS aligned with ISO 13485:2016.
• Lead design controls, risk management, and technical documentation.
• Drive regulatory submissions and approvals for CDSCO, US FDA (510(k)), and EU MDR.
• Manage internal/external audits, CAPA, and quality performance metrics.
• Oversee supplier quality, manufacturing validation, and process controls.
• Support packaging, sterilisation validation, and post-market surveillance.
• Implement effective document control and training systems.
• Collaborate with cross-functional engineering and product development teams. ? Qualifications &

Skills:
• Bachelor's degree in Engineering, Biomedical Sciences, Life Sciences, or a related field.




• 5–7 years of experience in Quality Assurance and Regulatory Affairs for medical devices.
• Hands-on experience implementing ISO 13485 and preparing regulatory submissions.
• Robust understanding of ISO 14971, IEC 62304, IEC 60601, IEC 62366-1, ISO 10993, ISO 11607, and Indian Medical Devices Rules, 2017.
• Familiarity with Class II or higher-risk medical devices and international regulatory pathways.
• ISO 13485 Internal Auditor certification preferred. ? What We're Looking For A proactive, detail-oriented professional who can take ownership of quality and regulatory activities, work closely with multidisciplinary teams, and help bring safe, compliant medical devices to market. ? Interested candidates can share their resumes or reach out via LinkedIn DM.
• #Hiring #QARALead #MedicalDevices #QualityAssurance #RegulatoryAffairs #ISO13485 #CDSCO #USFDA #EUMDR #BengaluruJobs #MedTech #HealthcareInnovation

📌 QARA Lead/Senior (Bengaluru)
🏢 Foundation for Science, Innovation and Development, IISc Bangalore
📍 Bengaluru