Job Summary
Experience:
5.00 - 10.00 Years
Industrial Type:
IT-Software/Software Services
Location:
Bangalore
Functional Area:
IT Software - Client Server
Designation:
Senior Quality Assurance Associate / Lead
Key Skills:
Quality Assurance
Educational Level:
Graduate/Bachelors
Job Post Date:
2026-10-22
Stream of Study:
Engineering
Degree:
BE-Comp/IT, BE-Other, BSc-Comp/IT, BSc-Other, BTech-Comp/IT, BTech-Other
Company Description
Our client is a platform-first biotech company pioneering fast, scalable, and accessible CRISPR-based solutions. They translate cutting-edge gene technologies into powerful tools for diagnostics, disease screening, and genome engineering, designed not just for advanced laboratories, but for any setting where they are needed most. They reimagine what CRISPR can do by engineering it to work faster, more economically, and without dependence on heavy infrastructure. Our platforms are modular, programmable, and optimized for real-world deployment, from remote clinics to research labs and field environments.
Job Description
Key Responsibilities
Regulatory Affairs — CDSCO (Primary Focus)
• Own regulatory planning and execution for CDSCO Class C medical devices/IVDs, including applicable licenses, registration submissions, dossier preparation, query responses, amendments and ongoing post-approval compliance.
• Interpret and implement applicable Medical Devices Rules, 2017 requirements, CDSCO guidance, labelling/IFU requirements and relevant Indian standards across the product lifecycle.
• Compile and maintain product technical documentation, device descriptions, intended use, classification rationale, performance evaluation, risk management, manufacturing and quality evidence, and required regulatory records.
• Coordinate with notified bodies, testing laboratories, clinical/performance-evaluation partners and internal stakeholders to support approvals, inspections and regulatory commitments.
• Support change-impact assessments, vigilance/complaint reporting, field actions and regulatory updates, as applicable.
International Regulatory Readiness (Desirable)
• Support gap assessments and documentation readiness for European CE-IVD under the IVDR and US FDA IVD pathways, where relevant.
• Exposure to EU technical documentation, performance evaluation, US FDA submissions (e.g., 510(k)/De Novo where applicable), QMS expectations and regulator communications is beneficial; direct international submission experience is an advantage.
Quality Management System & Audit Compliance
• Maintain and continuously improve an ISO 13485-aligned QMS, including document control, internal audits, supplier quality, nonconformance/deviation management, CAPA, change control and management review.
• Coordinate internal and external audits and regulatory inspections; ensure timely closure of observations using structured root-cause analysis and effectiveness checks.
• Ensure appropriate risk management, traceability and data integrity practices throughout design transfer, manufacture and post-market activities.
Technical Documentation, Validation & Manufacturing Quality
• Oversee controlled SOPs, device master/production records, batch manufacturing records, design and development files, risk files, verification/validation reports, stability evidence and technology-transfer documentation.
• Work with R&D, QC and manufacturing on acceptance criteria, process validation, analytical/clinical performance studies, product release controls and inspection readiness.
• Coordinate equipment qualification/calibration, environmental records and other manufacturing quality evidence in support of regulatory submissions and routine compliance.
Cross-functional Coordination & Training
• Act as a regulatory and quality point of contact for R&D, manufacturing, QC, clinical and business teams; maintain regulatory timelines and communicate submission risks and dependencies.
• Train and mentor team members on regulatory documentation, ISO 13485 processes, data integrity, CAPA and compliance expectations.
Required Skills & Experience
• 5–7 years of relevant professional experience in Regulatory Affairs and/or Quality Assurance within the medical device or IVD/diagnostics industry; hands-on regulatory ownership is strongly preferred.
• Demonstrated experience preparing or supporting CDSCO submissions for medical devices, preferably Class C IVD/medical devices, including regulatory dossiers, responses to queries and license/lifecycle documentation.
• Working knowledge of India’s Medical Devices Rules, 2017, CDSCO expectations, medical device classification and relevant IVD performance and clinical evidence requirements.
• Practical experience with ISO 13485 QMS, audit/inspection readiness, technical documentation, risk management, CAPA, change control and product traceability.
• Experience coordinating with cross-functional teams on analytical/clinical performance evaluation, verification/validation, manufacturing readiness and controlled documentation.
• Exposure to CE-IVD/European IVDR and/or US FDA requirements, submissions or audits would be a strong advantage, but is not mandatory.
• Familiarity with molecular diagnostics, PCR or CRISPR-based assays is desirable.
• Strong regulatory writing, organization, stakeholder coordination, problem-solving and communication skills.
