Regulatory Affairs Associate & Medical Laboratory Technologist. Postgraduate degree in Analytical Biochemistry. 2+ years remote regulatory affairs, 3+ years clinical lab experience. Native Arabic · C2 English · C1 Turkish · B1 Spanish. Open to remote regulatory affairs, IVD support, medical translation & transcription worldwide.
Salma A
@salmaa
Regulatory Affairs Associate and Medical Laboratory Technologist
What I'm looking for
I’m a Medical Laboratory Technologist and Regulatory Affairs Associate with a background in chemistry and analytical biochemistry, plus strong clinical laboratory practice. I combine technical laboratory capability with regulatory support to help diagnostic products move forward compliantly and confidently.
In my current role, I support product registrations, regulatory submissions, document updates, and authority follow-up for medical equipment, laboratory kits, diagnostic kits, and reagents with authorities. I review regulatory documents, product information, labels, and packaging for compliance, while maintaining accurate registration trackers, renewal schedules, submission records, and regulatory files.
Previously as a Medical Laboratory Technologist, I processed approximately 50 patient samples per day across biochemistry, hematology, urinalysis, serology, and ELISA, with accurate LIS documentation and result verification. I performed confirmatory manual testing for abnormal/flagged results, supported analyzer operation and daily quality control using Levey-Jennings charts and basic Westgard rules under senior supervision, and escalated out-of-control QC results.
I’m detail-oriented and organized, and I enjoy working across both technical laboratory tasks and regulatory documentation. I manage reagent usage and expiry tracking in Excel and LIS, maintain quality records, support stock rotation and ordering, assist with specimen integrity and biosafety, and contribute to document control and labeling compliance.
Experience
Work history, roles, and key accomplishments
Regulatory Affairs Associate
Al Quds General Trading Company
Sep 2023 - Present (2 years 9 months)
Supported product registrations and regulatory submissions for medical equipment and diagnostic kits/reagents, updating documentation and following up with UAE authorities. Reviewed labels and packaging for UAE compliance while maintaining accurate registration trackers, renewal schedules, and submission records.
Medical Laboratory Technologist
Kayan Medical Analysis Laboratory
Nov 2020 - Jul 2023 (2 years 8 months)
Processed approximately 50 patient samples per day across biochemistry, hematology, urinalysis, serology, and ELISA with accurate LIS documentation and result verification. Performed confirmatory manual testing for abnormal results, supported analyzer operation with daily QC (Levey-Jennings, Westgard rules), and managed reagent expiry tracking and quality records.
Education
Degrees, certifications, and relevant coursework
Benha University
Postgraduate Diploma, Analytical Biochemistry
2021 - 2022
Completed a Postgraduate Diploma in Analytical Biochemistry at the Faculty of Science, Benha University.
Ain Shams University
Bachelor of Science, Chemistry-Botany
2016 - 2021
Completed a BSc in Science (Chemistry-Botany) at the Faculty of Science, Ain Shams University.
The Westminster School
IGCSE
Completed IGCSE studies at The Westminster School in the United Arab Emirates.
Availability
Location
Authorized to work in
Job categories
Skills
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