On-site
Full Time
🎓 Master’s in Biology / Biotechnology / Life Sciences
🧾 3–5 years’ experience in regulatory documentation for sterile or IVF-related products
✅ DCGI submissions & Product/ Site Master Files
✅ ISO 13485:2016 QMS documentation
✅ CE marking, MDR/IVDR compliance
✅ Knowledge of Drugs & Cosmetics Act, Medical Device Rules (2017)
📄 Prepare and maintain regulatory dossiers, technical files & SOPs
🤝 Collaborate with QA, RA & R&D for submissions
🔍 Support audits, product registrations & renewals
Meril
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