Regulatory & Quality Assurance Manager – Medical Devices & Drugs

About the role

Fresenius Medical Care seeks a Manager to lead regulatory and quality activities for both medical devices and pharmaceuticals in Pakistan. The role ensures compliance with local and international regulations, supports market access, and safeguards patient safety throughout the product lifecycle.

Key responsibilities

• Manage medical device and drug registration processes with the Drug Regulatory Authority of Pakistan (DRAP) and other health agencies.
• Prepare and submit registration dossiers, renewals, change notifications, and post‑market surveillance documentation.
• Maintain and update the Regulatory Information Management System (RIMS) to keep product information accurate and current.
• Oversee pharmacovigilance activities, including adverse event reporting and acting as the responsible person.
• Handle customer complaints, coordinate regulatory audits, and ensure proper documentation management.
• Provide regular updates to global teams on local regulatory status and changes.

Required profile

• Proven experience in medical device and drug registration within Pakistan.
• Familiarity with DRAP regulations and local legislative requirements.
• Ability to liaise with health authorities and negotiate approvals.
• Strong organizational skills for managing multiple regulatory dossiers simultaneously.

Required skills

• Regulatory Information Management System (RIMS) usage.
• Medical device and pharmaceutical registration processes.
• Pharmacovigilance and adverse event reporting.
• Customer complaint handling and regulatory audit preparation.

What we offer

• Opportunity to work within a global leader in kidney care.
• Collaborative environment with cross‑functional teams.
• Impactful role contributing to patient safety and product quality.