Senior Quality Assurance Associate / Lead

Sampoorna Computer People; Bengaluru; On-site; INR 900,000 - 2,000,000; Full time

Job summary

Sampoorna Computer People in Bengaluru seeks a Regulatory Affairs specialist to own regulatory planning for CDSCO Class C medical devices/IVDs, including licenses, submissions, dossier prep, and post-approval compliance under Indian rules.

You will coordinate with testing laboratories, notified bodies and internal teams to support approvals, inspections and regulatory commitments; maintain ISO 13485 aligned QMS, audits, CAPA, change control, risk management and data integrity across the product

Qualifications

• 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.
• 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.

Responsibilities

• Regulatory planning and execution for CDSCO Class C medical devices/IVDs, including licenses, submissions and post-approval compliance.
• Interpret and implement Indian Medical Devices Rules, 2017 requirements, CDSCO guidance, labelling/IFU and relevant standards.
• Compile and maintain product technical documentation, device descriptions, rationale, risk management, and evidence for regulatory records.
• Coordinate with notified bodies, testing labs and internal stakeholders to support approvals, inspections and commitments.
• Support change-impact assessments, vigilance/complaint reporting and regulatory updates as applicable.
• Maintain and continuously improve an ISO 13485-aligned QMS, including document control, internal audits and CAPA.
• Coordinate audits and regulatory inspections; ensure timely closure of observations with root-cause analysis.
• Ensure risk management, traceability and data integrity across design transfer, manufacturing and post-market activities.

Skills

Regulatory Affairs

Quality Assurance

CDSCO Submissions

ISO 13485 QMS

Audit Readiness

Technical Documentation

Risk Management

Cross-functional

Regulatory Writing

Data Integrity

CE/FDA Exposure

Molecular Diagnostics

Communication Skills

Job description

Role & responsibilities

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.