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Regulatory Affairs Specialist

4 weeks ago


Vapi, India Meril Full time

Join our team as a Regulatory Documentation Specialist focused on IVF buffer media and sterile life science products. The ideal candidate will have strong expertise in regulatory compliance & documentation.Qualifications:🎓 Master’s in Biology / Biotechnology / Life Sciences🧾 3–5 years’ experience in regulatory documentation for sterile or IVF-related productsKey Skills:✅ 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)✅ Knowledge of WHO-GMP standards.Responsibilities:📄 Prepare and maintain regulatory dossiers, technical files & SOPs🤝 Collaborate with QA, RA & R&D for submissions🔍 Support audits, product registrations & renewalsKindly mail your update resume on vaishnavi.kadam@merillife.com