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.