Regulation and QA Specialist

Key Responsibilities
• Managing the QMS of the company in compliance with international standards e.g., ISO13485; 2016;.
• Managing the ISMS (information security management system) in compliance with ISO27001, ISO27799 and HIPAA.
• Providing regulatory support with any additional regulatory requirement that is arising (such as meaningful use certification, CE…)
• Work with all departments to make sure that quality and regulatory aspect are taken into consideration in design, development and marketing.
• Presenting the company during audits
• Performing audits at suppliers.
• Tracing and monitoring regulatory changes in the industry.
Experience Required
• B.A/ B.Sc. degree in science, engineering or related fields.
• At least 3 years of experience in quality and regulation in a medical device/medical software company -must
 
Qualifications and Personal Characteristics
• High level of English
• Details oriented
• Team player
• Self-motivated
• Highly developed Communication skills (written & verbal).