IVF Documentation

1 day ago

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

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

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