Quality Analyst and Regulatory Affairs

Roles & Responsibilities

• Implement and maintain ISO 13485:2016 Quality Management System
• Support risk management activities as per ISO 14971
• Prepare and review regulatory submissions for CDSCO, US FDA, and EU MDR/IVDR
• Develop and maintain Design & Development documents, DHF, DMR, and Technical Files
• Manage IFU, labeling, SOPs, and regulatory documentation
• Support internal audits, external audits, and regulatory inspections
• Assist with software lifecycle documentation as per IEC 62304
• Support usability engineering activities per IEC 62366
• Coordinate with R&D, software, clinical, and operations teams
• Ensure continuous regulatory compliance and quality improvement

Qualification

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or Quality Management

Experience

• Experience in Medical Device Quality Assurance & Regulatory Affairs (QARA)
• Hands-on exposure to CDSCO, US FDA, and EU MDR/IVDR submissions

Skills

• Strong knowledge of ISO 13485, ISO 14971, ISO 15223-1, ISO 20417
• Familiarity with IEC 62304 and IEC 62366
• Excellent regulatory writing and documentation skills
• Strong analytical, organizational, and communication abilities

About the Organisation

Aytasense Technologies Pvt. Ltd. is a fast-growing medical device and digital health company developing SenseH, an advanced remote health monitoring solution that combines wearable sensors, AI-driven analytics, and real-time health insights, with a focus on global regulatory compliance and innovation.