Job Title

Job Title: Executive – Regulatory & Technical Documentation Department: Quality Assurance & Regulatory Affairs (QA / RA) – Women’s Health & Fertility Location: Vapi, Gujarat Reports To: Manager / Senior Manager – QA / RAJob Purpose: To prepare, review, and control technical, quality, and validation documentation for Women’s Health & Fertility / IVF medical devices, supporting R&D and Production activities, ensuring compliance with ISO 13485, IEC 60601-1, and applicable regulatory requirements, and enabling timely DCGI submissions, Test License approvals, and product commercialization.Key Responsibilities: – 1. QMS & Technical Documentation • Prepare, review, and maintain QMS documents, design documentation, DOE records, protocols, and technical reports for IVF and women’s health devices. • Ensure documentation aligns with ISO 13485 and IEC 60601-1 requirements. • Control the complete document lifecycle including creation, review, approval, revision, distribution, and archival. • Maintain document traceability, version control, and data integrity across R&D and Production.2. Validation & Qualification Documentation • Review and manage DQ, OQ, PQ, and sterilization validation documents relevant to IVF and embryology devices. • Support preparation and review of validation protocols, execution reports, and summary documents. • Ensure validation documentation supports regulatory compliance and clinical safety expectations. • Support documentation for process validation, bench testing, and stability studies for fertility devices.3. Regulatory Submissions & DCGI Support • Provide complete, accurate, and submission-ready documentation to Regulatory Affairs for DCGI submissions and Test License applications. • Support compilation and review of regulatory dossiers for IVF devices and related accessories. • Ensure documentation complies with DCGI requirements and current regulatory guidelines. • Track documentation timelines and ensure on-time availability for submissions.4. QA & RA System Implementation • Support effective implementation and maintenance of QA and RA systems for Women’s Health & Fertility products. • Ensure alignment between R&D, Production, and Quality documentation. • Support internal compliance checks and documentation reviews. • Assist in closing documentation gaps identified during audits or regulatory assessments.5. Continuous Improvement & Change Management • Drive continuous improvement of documentation systems, formats, and templates aligned with evolving regulatory guidelines. • Support document change control, impact assessments, and version updates. • Participate in initiatives to improve documentation efficiency, clarity, and audit readiness. • Support training initiatives related to documentation best practices.6. Cross-Functional Coordination • Coordinate with RA, QA, QC, R&D, Manufacturing, and Validation teams for documentation related to IVF devices. • Support documentation for process validation, bench testing, environmental testing, and stability studies. • Facilitate timely collection, review, and consolidation of inputs from cross-functional stakeholders. • Support internal and external audit preparation and responses.Qualifications and Experience: • B.Sc / M.Sc / B.E. / B.Tech / Diploma in Engineering, Life Sciences, or related discipline. • 3–6 years of experience in documentation within medical devices, IVF systems, diagnostics, or regulated manufacturing environments. • Hands-on experience with ISO 13485, IEC 60601-1, and DCGI documentation preferred. • Exposure to regulatory submissions and Test License documentation for medical devices is an advantage.Skills and Competencies: • Strong knowledge of QMS and regulatory documentation for medical devices. • Hands-on experience with validation documentation (DQ, OQ, PQ). • High attention to detail and documentation accuracy. • Understanding of Women’s Health / IVF device lifecycle and regulatory expectations. • Strong coordination and follow-up skills across cross-functional teams. • Proficiency in MS Word, Excel, and document control systems. • Good technical writing and communication skills.Key Performance Indicators (KPIs): • Timely completion of documentation supporting DCGI submissions and approvals. • Zero critical documentation gaps during audits or regulatory reviews. • Accuracy and completeness of validation and technical documentation. • Effective coordination with R&D, QA, RA, and Manufacturing teams. • Continuous improvement in documentation quality, compliance, and audit readiness.