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Meril Life Sciences, a global leader in life science innovation, is seeking a Regulatory Documentation Specialist to support regulatory operations for IVF buffer media and sterile life science products. This role is ideal for professionals experienced in regulatory submissions, compliance documentation, and ISO 13485 QMS.
If you have hands-on experience with medical device regulations (MDR/IVDR) and DCGI submissions, this is your chance to contribute to advancing healthcare innovation.
🧾 Key Responsibilities
As a Regulatory Documentation Specialist, you will:
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- Prepare, review, and maintain regulatory dossiers, Product Master Files, and Site Master Files.
- Ensure compliance with DCGI, ISO 13485:2016, MDR/IVDR, and WHO-GMP standards.
- Collaborate with Regulatory Affairs, Quality Assurance, and R&D teams for successful submissions.
- Support audits, product registrations, renewals, and responses to regulatory queries.
- Maintain up-to-date documentation in alignment with the Drugs & Cosmetics Act and Medical Device Rules (2017).
🎓 Qualifications & Experience
Education:
- Master’s degree in Biology, Biotechnology, or Life Sciences.
Experience:
- 3–5 years of experience in regulatory documentation for sterile or IVF-related products.
Key Skills:
- Proficiency in DCGI submissions, CE marking, and ISO 13485 documentation.
- Strong understanding of Indian and international regulatory frameworks.
- Excellent communication and technical documentation skills.
💼 Why Join Meril Life Sciences?
- Work in a cutting-edge life science environment with global exposure.
- Contribute to innovative IVF and sterile product development.
- Competitive salary package and career growth opportunities.
- Collaborative and quality-driven work culture.
📩 How to Apply
Interested candidates can share their updated resume at:
📧 vaishnavi.kadam@merillife.com
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