IVF Documentation Senior Executive

2 days ago


Vapi, Gujarat, India Meril Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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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