IVF Documentation Senior Executive
2 days ago
Regulatory Documentation Specialist focused on IVF buffer media and sterile life science products. The ideal candidate will have strong expertise in regulatory compliance, documentation, and quality systems aligned with DCGI, ISO 13485, CE (MDR/IVDR), and WHO-GMP standards.
Qualifications:
Masters 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)
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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