Job Description

● Department: Quality Assurance and Regulatory Affairs

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● Reports to: QARA Manager

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● Experience: 3 to 5 years in medical devices

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● Location: Hybrid– (BTM Layout, Bangalore)

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

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● Employment Type: Full-time

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Role Overview

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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.

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Key Responsibilities

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• Maintain the QMS: Quality Manual, SOPs, WIs, and document control.

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• Support production quality: DHR, DoC and batch release

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• Manage change control, deviations, CAPA, and internal/external audits.

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• Prepare and maintain Technical Files for hardware and SaMD products across India, EU, US, and

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similar markets.

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• Support SaMD-specific documentation: software lifecycle (IEC 62304), risk classification, and usability engineering.

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• Liaise with regulators and notified bodies; respond to queries and assess regulatory impact of product changes.

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• Review labelling/promotional material for compliance; handle vigilance and recall reporting.

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• Track regulatory intelligence and advise project teams.

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What We're Looking For

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• Detail-oriented, strong documentation habits

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• Familiarity with SaMD classification and software regulatory pathways

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• Comfortable on the shopfloor and with regulators alike

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• Positive communicator, able to juggle priorities

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• Proactive, solution-driven mindset

📌 QARA Specialist (Bengaluru)
🏢 Tricog Health
📍 Bengaluru