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-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

📌 Hiring: QARA Specialist (India)
🏢 Tricog Health
📍 India