Job Description ● Department: Quality Assurance and Regulatory Affairs
n ● Reports to: QARA Manager
n ● Experience: 3 to 5 years in medical devices
n ● Location: Hybrid– (BTM Layout, Bangalore)
n ● Qualification: Bachelor's degree in engineering, sciences or Pharma
n ● Employment Type: Full-time
n Role Overview
n 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.
n Key Responsibilities
n • Maintain the QMS: Quality Manual, SOPs, WIs, and document control.
n • Support production quality: DHR, DoC and batch release
n • Manage change control, deviations, CAPA, and internal/external audits.




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

📌 QARA Specialist (Bengaluru)
🏢 Tricog Health
📍 Bengaluru