Job Type: Full time

Remote: Hybrid

● 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-timeRole OverviewThe 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, andsimilar 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 (Prayagraj)
🏢 Tricog Health
📍 Prayagraj