● Department: Quality Assurance and Regulatory Affairs

● Reports to: QARA Manager

● Experience: 3 to 5 years in medical devices

● Location: Hybrid– (BTM Layout, Bangalore)

● Qualification: Bachelor’s degree in engineering, sciences or Pharma

● Employment Type: Full-time Role Overview The QA RA Specialist owns quality operations and QMS execution across manufacturing, while driving regulatory affairs — technical files, submissions, and regulator/notified body liaison — for both hardware devices and SaMD products. Work closely with Production, QC, R&D;, and Supply Chain to ensure compliance with ISO 13485:2016, CDSCO IMDR, EU MDR, and IEC 62304/62366-1 across the product lifecycle. Key Responsibilities

- Maintain the QMS: Quality Manual, SOPs, WIs, and document control.
- Support production quality: DHR, DoC and batch release
- Manage change control, deviations, CAPA, and internal/external audits.




- Prepare and maintain Technical Files for hardware and SaMD products across India, EU, US, and similar markets.
- Support SaMD-specific documentation: software lifecycle (IEC 62304), risk classification, and usability engineering.
- Liaise with regulators and notified bodies; respond to queries and assess regulatory impact of product changes.
- Review labelling/promotional material for compliance; handle vigilance and recall reporting.
- Track regulatory intelligence and advise project teams. What We're Looking For
- Detail-oriented, strong documentation habits
- Familiarity with SaMD classification and software regulatory pathways
- Comfortable on the shopfloor and with regulators alike
- Positive communicator, able to juggle priorities
- Proactive, solution-driven mindset

📌 QARA Specialist (Bengaluru)
🏢 Tricog Health
📍 Bengaluru