Regulatory Documentation Specialist IVF / Sterile Products at Meril Life Sciences
Company: Meril Life Sciences
Role: Regulatory Documentation Specialist – IVF & Sterile Products
Location: Vapi, Gujarat
Qualification: Master’s degree in Biology, Biotechnology, or Life Sciences
Experience: 3–5 years
Application Mode: Email
Job Type: Full Time
Status: Verified Job
About the Company
Meril Life Sciences is a leading global medical device and life sciences company committed to advancing healthcare through innovation and quality. The company’s IVF and sterile products division focuses on developing advanced solutions aligned with international standards, including ISO 13485 and other regulatory requirements. Working at Meril offers professionals the opportunity to contribute to meaningful innovations in the medical and life sciences sector. Regulatory Documentation Specialist IVF / Sterile Products at Meril Life Sciences
Job Description
Meril Life Sciences is looking for a skilled and experienced Regulatory Documentation Specialist to support its IVF buffer media and sterile product portfolio. The selected candidate will play a key role in preparing, reviewing, and maintaining regulatory documentation to ensure compliance with both Indian and international standards. Regulatory Documentation Specialist IVF / Sterile Products at Meril Life Sciences
Key Responsibilities
- Prepare, review, and maintain regulatory dossiers, Product Master Files (PMF), and Site Master Files (SMF).
- Ensure compliance with DCGI, ISO 13485:2016, MDR/IVDR, and WHO-GMP standards.
- Collaborate with Regulatory Affairs, Quality Assurance, and R&D teams to ensure successful submissions.
- Support audits, product registrations, renewals, and responses to regulatory authority queries.
- Maintain up-to-date documentation in line with the Drugs & Cosmetics Act and Medical Device Rules (2017).
- Coordinate with cross-functional teams to ensure timely completion of documentation requirements.
- Review technical documents to ensure accuracy, consistency, and completeness before submission.
- Regulatory Documentation Specialist IVF / Sterile Products at Meril Life Sciences
Qualifications and Experience
Educational Qualification:
- Master’s degree in Biology, Biotechnology, or Life Sciences.
Experience Required:
- Minimum 3–5 years of experience in regulatory documentation for sterile or IVF-related products.
Key Skills and Competencies
- Proficiency in DCGI submissions, CE marking, and ISO 13485 documentation.
- Strong understanding of Indian and international regulatory frameworks.
- Excellent communication and technical writing skills.
- Ability to handle multiple projects with attention to detail and accuracy.
- Good coordination and teamwork skills for cross-functional collaboration.
- Experience in maintaining QMS and regulatory document control systems.
- Regulatory Documentation Specialist IVF / Sterile Products at Meril Life Sciences
Why Join Meril Life Sciences
- Opportunity to work in a globally reputed life science organization.
- Exposure to cutting-edge technologies in IVF and sterile product development.
- Competitive salary and performance-driven career growth opportunities.
- Collaborative, quality-focused, and innovation-driven work culture.
- Regulatory Documentation Specialist IVF / Sterile Products at Meril Life Sciences
How to Apply
Interested and eligible candidates can share their updated resume to the following email address:
Email ID: vaishnavi.kadam@merillife.com
Job Summary
| Particulars | Details |
|---|---|
| Company | Meril Life Sciences |
| Position | Regulatory Documentation Specialist – IVF & Sterile Products |
| Qualification | Master’s degree in Biology, Biotechnology, or Life Sciences |
| Experience | 3–5 years |
| Location | Vapi, Gujarat |
| Application Mode | |
| Industry Type | Medical Devices / Life Sciences |
| Status | Verified Job |
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