Pharmacist for Medical Devices

Regulatory Affairs Pharmacist – Medical Device Registration, DRAP Compliance & Tendering Position

Title:

Regulatory Affairs & Business Development (Medical Devices)

Location: Rawalpindi

Employment Type: Full-Time / Contractual

Experience Required:

Minimum 5–8 years (Medical Device / Pharmaceutical Regulatory & Tendering) Job Purpose:

To lead and manage the end-to-end registration of medical devices with the Drug Regulatory Authority of Pakistan (DRAP), ensure full regulatory compliance across all product portfolios, and drive business growth through strategic participation in government and private tendering/bidding processes.

Key Responsibilities:

A. DRAP Medical Device Registration & Licensing • Prepare, compile, and submit complete registration dossiers for medical devices (Class A, B, C, D) with DRAP in accordance with the Medical Devices Rules, 2017 and subsequent amendments. • Liaise directly with DRAP officers, attend pre-submission meetings, and respond to queries/deficiency letters within stipulated timelines. • Coordinate with international manufacturers/principals for technical documentation (CE Certificates, ISO 13485, Free Sale Certificates, Clinical Evaluation Reports, IFU, labelling).

B. Regulatory Compliance & Quality Assurance • Ensure all marketed medical devices comply with DRAP regulations, Pakistan Standards (PSQCA), and applicable international standards (FDA, ISO 13485, IEC 60601, EU MDR/IVDR where relevant).

C. Tendering & Business • Development Identify, monitor, and track tender opportunities from government hospitals, provincial health departments • Prepare comprehensive tender/bid documents including technical proposals, commercial offers, compliance matrices, and supporting regulatory certificates. • Ensure all tender submissions meet eligibility criteria, DRAP registration prerequisites, and technical specifications.

Qualifications & Requirements: • Education Doctor of Pharmacy (Pharm.D) / B.Pharm (minimum) from a recognized university • Licensing Valid registration with the Provincial Pharmacy Council • Experience 5–8 years in Regulatory Affairs, Medical Device Registration, and/or Tendering within Pakistan's healthcare/pharma sector Regulatory Knowledge In-depth understanding of DRAP Act 2012. • Technical Skills MS Office (advanced Excel, Word, PowerPoint); familiarity with DRAP online portals; ERP/CRM systems • Preferred Prior experience working directly with DRAP's Medical Device Division. Experience with CE-marked / FDA-cleared device dossiers. Familiarity with ISO 13485, ISO 14971 (Risk Management), IEC 62366 (Usability).

Compensation & Benefits: Competitive salary commensurate with experience (PKR 50000-70000 per month). Performance-based bonus linked to tender wins and registration milestones. Professional development opportunities (conferences, DRAP workshops, international training)

Pay: Rs50,000.00 - Rs70,000.00 per month

Work Location: In person