Sterile Products Documentation Specialist

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 products

Key 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 & renewals

Kindly mail your update resume on vaishnavi.kadam@merillife.com