QARA Specialist

● 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