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Job Description
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
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