Bio-Standards
Wafaa Mohammad is a seasoned professional in regulatory affairs and quality assurance, currently serving as the Regulatory Affairs and Quality Assurance Director and Head of the Medical Devices Regulatory Department at Bio-Standards since June 2019. Notable achievements include supervising the approval of over 2500 requests with the SFDA and establishing the company's quality management system compliant with ISO 13485 and ISO 9001 standards. Previous experience spans various roles, including Regulatory Affairs Specialist and Associate at Bio-Standards, a Sales Associate at a cosmetics company, and a Graphic Designer for a municipal initiative. Wafaa also has experience as a Research Assistant in a university setting and has held positions in digital marketing and business development. Educational qualifications include a Bachelor's degree in Biomedical/Medical Engineering from Imam Abdulrahman Bin Faisal University.
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Bio-Standards
About us: Bio-Standards was established in 2010 as a regulatory representative specialising in product registration with the Saudi Food & Drug Authority (SFDA) and local markets access for international manufacturers of Medical Devices and Pharmaceuticals. Our team members understand SFDA regulations in detail and are skilled in overcoming difficult challenges and providing our clients with the best compliance & logistic strategy. This approach enables us to create comprehensive solutions for all relevant parties to gain smooth access to the Saudi market and surrounding countries. Bio-Standards handle all the sensitive tasks to their maximum intensities with professional integrity, accuracy, and transparency. Mission: To facilitate the access of International manufacturers to the Saudi Market and surrounding countries by meeting specific local regulations and requirements with integrity and perfection. Vision: To be the leading consulting firm and regulatory affairs expert in the Kingdom of Saudi Arabia & GCC countries.