Compliance Officer – Medical Product Fulcrum Pvt LTD
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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
Key Skills
- Compliance Management
- Risk Management
- Financial Services
- PCI
- Banking
- Cost Accounting Standards
- Quality Systems
- Research Experience
- NIST Standards
- Securities Law
- SOX
- ISO 27000
