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
nRole Overview
nThe 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.
nKey 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
nsimilar 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.
nWhat We're Looking For
n• Detail-oriented, solid documentation habits
n• Familiarity with SaMD classification and software regulatory pathways
n• Comfortable on the shopfloor and with regulators alike
n• Good communicator, able to juggle priorities
n• Proactive, solution-driven mindset

📌 QARA Specialist (Karnataka)
🏢 Tricog Health
📍 Karnataka