Regulatory Affairs and Tender Management Specialist - TJ / 1874542

Our client AM Distributors is looking for a Regulatory Affairs and Tender Management Specialist in Karachi

AM Distributors seeks a diligent Regulatory Affairs & Tender Management Officer to ensure full compliance with all Drug Regulatory Authority of Pakistan (DRAP) regulations and legal mandates concerning medical devices. This position involves comprehensive management of regulatory submissions and documentation, including preparation, coordination, and timely filing of dossiers for new registrations, renewals, and amendments with the regulatory authority. The officer is responsible for managing the entire tender submission process for government and hospital contracts, handling documentation control, and maintaining adherence to all Medical Device Rules from 2017, 2018, and related statutory regulatory orders. The role requires maintaining clear and effective communication with DRAP authorities, acting as the primary liaison, and ensuring all legal and regulatory changes are promptly addressed and implemented by the company.

This position demands a candidate with a degree in Pharmacy, Biomedical Engineering, or Life Sciences, and 3 years of related experience, preferably with direct exposure to DRAP operations. The officer does not manage a team but must effectively coordinate with internal stakeholders and external regulatory bodies to guarantee seamless regulatory compliance and successful tender submissions. Strong skills in documentation, regulatory compliance frameworks, and tender management software are essential to thrive in this role and support the companys operational and legal objectives.

Responsibilities

• Prepare and submit dossiers for initial registration, renewal, and amendments of medical devices with DRAP, ensuring completeness and accuracy.
• Manage end-to-end government and hospital tender submissions including preparation, coordination, and timely submission of all required documentation.
• Maintain and control all regulatory documentation including technical files, labeling, Instructions for Use (IFU), and legal documents associated with medical devices.
• Ensure continuous compliance with the Medical Device Rules 2017, 2018, and all relevant statutory regulatory orders, keeping the company informed on regulatory updates and changes.
• Act as the primary interface with DRAP authorities, handling all regulatory correspondence and ensuring timely responses to inquiries or regulatory requirements.
• Obtain necessary No Objection Certificates (NOCs), import permits, and fulfill legal requirements related to import and export activities of medical devices.
• Prepare and maintain regulatory records and documentation in readiness for internal and external audits.
• Coordinate and obtain regulatory approval for any modifications or changes made to registered medical device products.
• Use regulatory submission software and electronic document control systems such as eCTD to maintain compliance and efficiency in documentation management.
• Utilize tender and contract management software to streamline and track tender submissions and approvals.
• Collaborate with cross-functional teams to ensure timely submission of all regulatory and tender-related deliverables, fostering effective stakeholder communication.
• Monitor regulatory intelligence and industry trends to anticipate and adapt to upcoming regulatory changes impacting medical device registrations and tender processes.
• Implement and support the regulatory compliance frameworks within the organization to ensure alignment with national and international regulatory standards.