Regulatory Affairs & Tender Management Officer – Karachi

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

Regulatory Affairs & Tender Management Officer – Karachi

Job Purpose:
To ensure compliance with all DRAP regulations and legal requirements for the company's medical devices, and to manage all regulatory submissions and documentation.
Key Responsibilities:
DRAP Registration: Prepare and submit dossiers for new registration, renewal, and amendments of all medical devices with DRAP.
Responsible for end-to-end management of government & hospital tender submission
Documentation: Complete all required forms, technical files, labeling, IFU [Instructions for Use], and other legal documents.
Legal Compliance: Ensure adherence to all Medical Device Rules 2017, 2018, and relevant SROs. Keep the company updated on all regulatory changes.
Liaison: Act as the primary point of contact with DRAP authorities and handle all regulatory correspondence.
Import/Export: Obtain NOCs, import permits, and fulfill all other legal requirements for import/export.
Audits: Maintain and prepare all regulatory records for internal and external audits.
Product Changes: Obtain regulatory approval for any changes made to registered products.
Required Qualifications:
Education: Degree in Pharmacy, Biomedical Engineering, or Life Sciences.
Experience: 2-3 years of experience working with DRAP is preferred.
Skills: Experience in dossier preparation, knowledge of DRAP portal, and understanding of legal documentation & end to end tender submission.