Aytasense Technologies Private Limited, a fast-growing medical device and digital health company, is hiring a Quality Analyst and Regulatory Affairs professional for its Bengaluru (on-site) location. This is a full-time medical device QARA job ideal for professionals with experience in ISO 13485, CDSCO, US FDA, and EU MDR/IVDR documentation.
Aytasense is the developer of SenseH, an advanced remote health monitoring solution leveraging wearable sensors, AI algorithms, and real-time health analytics. This role offers hands-on exposure to global regulatory submissions, quality management systems, and software medical device compliance, making it a strong career opportunity in the medical device regulatory affairs domain.
Key Responsibilities – Quality Analyst & Regulatory Affairs
- Support implementation and maintenance of ISO 13485:2016 Quality Management System
- Assist in risk management activities as per ISO 14971
- Prepare, review, and support regulatory submissions for:
- CDSCO (India)
- US FDA
- EU MDR / IVDR (2017/745 & 2017/746)
- Develop and maintain Design & Development documentation
- Manage Technical Files, DHF, DMR, IFU, labeling, and SOPs
- Support internal audits, external audits, and regulatory inspections
- Assist with IEC 62304 software lifecycle documentation
- Support usability engineering activities as per IEC 62366
- Coordinate with cross-functional teams (R&D, software, clinical, operations)
- Ensure continuous regulatory compliance and quality improvement
Required Qualifications & Skills
- Experience in a Medical Device Quality Assurance & Regulatory Affairs (QARA) role
- Strong working knowledge of:
- ISO 13485
- ISO 14971
- ISO 15223-1
- ISO 20417
- Familiarity with IEC 62304 and IEC 62366
- Hands-on experience with CDSCO, US FDA, EU MDR/IVDR documentation
- Excellent regulatory writing and documentation skills
- Strong analytical, organizational, and communication abilities
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or Quality Management
Why Join Aytasense Technologies?
- Work on innovative digital health & wearable medical devices
- Exposure to global regulatory frameworks
- Opportunity to build expertise in software as a medical device (SaMD)
- Collaborative, technology-driven healthcare environment
- Strong career growth in medical device regulatory affairs
Job Location
Bengaluru, Karnataka, India
(On-site | Full-time)
Salary (Expected Range)
₹5,00,000 – ₹9,00,000 per annum
(Salary may vary based on experience and regulatory exposure)
How to Apply
Interested and eligible candidates should email their updated resume to:
Subject line: Application for Quality Analyst and Regulatory Affairs – Bengaluru
Apply early, as this is an active hiring medical device regulatory job.
