Alaa Mohammad
Regulatory Affairs Specialist Ii @ThermoFisher Scientific
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WORK HISTORY
Regulatory Affairs Specialist Ii @ThermoFisher Scientific
I serve as the regulatory lead for product development initiatives targeting both EU and US markets. My responsibilities encompass the authoring, review, and maintenance of regulatory documentation in accordance with global regulatory requirements, including IVDR, FDA 21 CFR, and MDSAP frameworks.I contribute to the preparation and compilation of global regulatory submissions, such as:CE technical documentation (STED format)510(k) and De Novo submissions for the US FDACLIA categorization and Q-submissions for regulatory strategy and feedbackI provide regulatory guidance throughout the product lifecycle, ensuring compliance from early-stage design through post-market surveillance. This includes close collaboration with cross-functional teams (R&D, Quality, Clinical, Manufacturing) to ensure design control documentation aligns with regulatory expectations and risk management principles (ISO 14971, FMEA).My role also supports Quality Management System (QMS) compliance, including internal audit readiness, third-party audit support, and continuous improvement activities under ISO 13485 and MDSAP standards. I maintain deep working knowledge of regulatory strategy for IVDs, with an emphasis on assay-based diagnostic platforms.
EDUCATION
University of Wolverhampton
Master of Science - MSc, Medical Biotechnology
University of Wolverhampton
Bachelor of Science- BMedSci, Medical Science
ABOUT ALAA MOHAMMAD
Regulatory Affairs Specialist with over 6 years of cross-functional experience across Regulatory, Quality, R&D, and Manufacturing within the medical device industry. With an MSc in Medical Biotechnology and a strong scientific foundation, I bring a well-rounded perspective to product development and regulatory compliance across both EU and US markets.
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