Regulatory Executive

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 / RA

Job 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.