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Urgent! Regulatory Executive Jobs | Meril
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.
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Unlock Your Regulatory Executive Potential: Insight & Career Growth Guide
Real-time Regulatory Executive Jobs Trends in Vapi, India (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Regulatory Executive in Vapi, India using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 42230 jobs in India and 156 jobs in Vapi. This comprehensive analysis highlights market share and opportunities for professionals in Regulatory Executive roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Meril is currently hiring and seeking a Regulatory Executive to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Meril adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Regulatory Executive Jobs India varies, but the pay scale is rated "Standard" in Vapi. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Regulatory Executive typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your Regulatory Executive interview at Meril, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Meril's products or services and be prepared to discuss how you can contribute to their success.
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