Compliance Officer – Medical Product - Fulcrum Pvt LTD

 Were Hiring: Compliance Officer (Medical Product) at Fulcrum.

Location: (Kemari Tower), Karachi

Experience Required: Minimum 2 Years

Qualification:

BE in Biomedical Engineering, Mechanical Engineering, or Industrial Engineering

Job Overview

The Compliance Officer – Medical Product will be responsible for ensuring that POL medical products, processes, and operations fully comply with applicable national and international regulatory and quality standards, including but not limited to FDA cGMP, ISO 13485, ISO 14971, and MDR/IVDR.

Key Responsibilities

• Ensure compliance with local and international medical product regulations
• Develop, review, and maintain SOPs, compliance reports, and regulatory documentation
• Support audits, inspections, and regulatory submissions
• Implement and monitor risk management frameworks (PDC)
• Coordinate with internal teams and external certification bodies

Key Skills & Competencies

• Strong SOP & report writing skills
• Excellent communication and documentation abilities
• Sound understanding of PDC risk management frameworks
• Knowledge of medical device & pharmaceutical compliance standards