● 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
• Good communicator, able to juggle priorities
• Proactive, solution-driven mindset
QARA Specialist • Mumbai, IN
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