Regulatory Affairs & Tender Lead – Medical Devices

A.M. Distributors; Karachi Division; Vor Ort; PKR 1.200.000 - 2.000.000; Vollzeit

Zusammenfassung

A.M. Distributors in Karachi seeks a Regulatory Affairs & Tender Management Officer to ensure DRAP compliance, manage regulatory submissions for medical devices, and oversee all tender-related documentation.

The role requires DRAP experience, strong dossier preparation skills, and familiarity with regulatory laws. You will liaise with authorities, manage import/export requirements, and support audits and product changes from our Karachi base.

Qualifikationen

• Degree in Pharmacy, Biomedical Engineering, or Life Sciences required.
• 2–3 years of DRAP experience preferred.
• Experience with dossier preparation and regulatory documentation is essential.

Aufgaben

• DRAP Registration: prepare and submit dossiers for new registrations, renewals and amendments.
• End-to-end government and hospital tender submission management.
• Complete all required forms, technical files, labeling, IFU, and other regulatory documents.
• Ensure compliance with Medical Device Rules 2017, 2018 and relevant SROs.

Kenntnisse

Dossier prep

DRAP portal

Tender submission

Regulatory compliance

Ausbildung

Degree in Pharmacy

Biomedical Engineering

Life Sciences

Jobbeschreibung

A.M. Distributors in Karachi seeks a Regulatory Affairs & Tender Management Officer to ensure DRAP compliance, manage regulatory submissions for medical devices, and oversee all tender-related documentation.

The role requires DRAP experience, strong dossier preparation skills, and familiarity with regulatory laws. You will liaise with authorities, manage import/export requirements, and support audits and product changes from our Karachi base.