Regulatory Officer – IVD

About the role

We are seeking a detail‑oriented Regulatory Officer specialized in In‑Vitro Diagnostics (IVD) to manage regulatory affairs, DRAP submissions, product registration, import documentation and compliance. The role requires close coordination with international principals, customs agents and internal teams to ensure timely market access for IVD products.

Key responsibilities

• Prepare and manage DRAP applications for IVD product registration, enlistment, import permissions, renewals and other regulatory approvals.
• Coordinate with international principals and suppliers to obtain technical documents, product specifications, certificates and other regulatory documentation.
• Prepare and verify import documentation (COA, COO, invoices, packing lists, Form‑1, Form‑11, PER) and track consignments for timely clearance.
• Maintain regulatory files, product dossiers, registration certificates and ensure compliance with DRAP regulations and internal SOPs.

Required profile

• Doctor of Pharmacy (Pharm‑D) degree.
• 1–2 years of experience in the diagnostics or IVD industry, with hands‑on experience in DRAP submissions and IVD product registration.
• Working knowledge of DRAP regulations, medical device requirements and import clearance procedures.

Required skills

• Practical experience with DRAP e‑Portals for regulatory submissions.
• Proficiency in Microsoft Office, especially Word and Excel.
• Strong documentation, communication and organizational abilities.