Muhammad Z.
Head of Quality Management and Regulatory Affairs @Selfapy
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WORK HISTORY
Head of Quality Management and Regulatory Affairs @Selfapy
Member of the senior management team, contributing to the definition and execution of company-wide strategic objectives.Lead annual planning and execution of initiatives related to Quality Management, Regulatory Affairs, and compliance to ensure alignment with business goals.Oversee the development, implementation, and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485, MDR, and FDA requirements.Successfully implemented a high-quality, fully automated electronic QMS (eQMS) to enhance compliance, streamline documentation, and enable scalable quality operations.Experienced in managing Software as a Medical Device (SaMD) in compliance with ISO 62304 and German Digital Health Applications (DiGA).Manage and maintain technical documentation and regulatory files across multiple product lines and cross-functional teams.Lead the company\'s risk management, CAPA, post-market surveillance (PMS), and internal/external audit programs.Serve as the primary contact for competent authorities, notified bodies, and regulatory agencies worldwide.Develop and manage departmental budgets, aligning resource planning with business needs and compliance priorities.Drive regulatory strategy for global market access, including CE marking, FDA 510(k), and other international registrations.Mentor and lead a multidisciplinary team including QM, RA, and compliance personnel; responsible for performance development and alignment.Coordinate cross-departmental training programs to ensure compliance awareness and regulatory readiness company-wide.Support new product development teams by integrating design control and regulatory pathways early in the product lifecycle.Maintain up-to-date knowledge of evolving regulations and proactively assess the impact of changes on the company’s operations and product portfolio.Spearhead quality and compliance culture initiatives, promoting operational excellence and continuous improvement.
EDUCATION
Shaheed Zulfikar Ali Bhutto Institute of Science and Technology
Masters, Project Management
Cologne University of Applied Sciences
Master's degree, Information System
Bahria University
Bachelor's degree, Computer Science
SKILLS
ABOUT MUHAMMAD Z.
Quality Management System ISO 13485• EU MDD/MDR• FDA- 510(k) Submission (K193438, K203505)• Developing SaMDs in compliance with ISO 62304• Project Management and leadership of cross-functional teams• Health Canada, South American countries, GCC Countries• Risk Management ISO 14971• Usability Engineering ISO 62366
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