Sarah Selim
Medical Device Regulatory Manager
Sheikh Zayed
Summary
Dedicated Regulatory and Compliance Manager with expertise in Medical Device Regulations (MDR), FDA approvals, and CE Mark compliance. Proven track record of aligning product development and business processes with regulatory standards, specifically in medical diagnostics and healthcare industries. Strong background in Quality Management Systems (QMS) and skilled at implementing MDR changes for device classification, resulting in streamlined operations across global markets.
Overview
15
15
years of professional experience
2
2
years of post-secondary education
Work History
REGULATORY COMPLIANCE MANAGER
PaxeraHealth International
2 2023 - Current
- Lead regulatory strategy for the company, ensuring adherence to global regulations, including CE marking for medical devices, FDA, and MDR.
- Spearheaded comprehensive MDR transition project that successfully reclassified products into higher-risk categories, ensuring continued market access in the EU.
- Managed FDA submissions (510(k)) for Class II medical devices, reducing approval time by 20%.
- Developed and maintained Quality Management Systems (QMS) compliant with ISO 13485, FDA, and CE Marking standards.
- Conducted gap analyses to identify areas needing improvement in existing compliance framework, initiating corrective action plans accordingly.
- Oversaw regulatory compliance for portfolio of products requiring CE Marking and FDA approval.
- Led cross-functional team to transition company's product classification under MDR guidelines, ensuring timely compliance with new regulatory requirements.
QUALITY MANAGEMENT SYSTEM (QMS) SUPERVISOR
Philip Morris International
01.2021 - 02.2023
- Oversaw daily operations of the department, ensuring smooth workflow and timely completion of tasks.
- Responsible for developing the Quality strategy, policies, processes, standards, and systems for the Company and its supply chain to operate within.
- Implemented corrective and preventive actions (CAPA) based on audit findings related to CE Mark non-conformities.
- Auditing to ensure compliance although this may be carried out by a third party accredited body.
MEDICAL MANAGER
Sunrise Infertility and IVF center
01.2019 - 01.2021
- Implementing new quality and documentation system, complying with SOP standards. Success rate in IVF techniques has increased by 30% after implementation of new quality strategy and techniques. Documented findings and produced reports to aid management in assessing and correcting quality concerns.
- Led continuous improvement initiatives aimed at enhancing service delivery models, while maintaining high-quality patient care standards across all departments.
- Improved patient care quality by implementing comprehensive medical management strategies and protocols.
MEDICAL PROJECT MANAGER
Flora Fusion
01.2018 - 01.2019
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Planned, designed, and scheduled phases for large projects.
PROJECT MANAGER
Vodafone UK
01.2014 - 01.2018
- Implemented a streamlined project management methodology, leading to a 15% improvement in project delivery timelines.
- Successfully led a cross-functional team of 10 members in the successful deployment of a new IT system, resulting in increased operational efficiency and cost savings.
- Achieved a 25% reduction in project costs through effective resource allocation and process optimization.
- Received recognition from senior leadership for outstanding performance in leading a complex international project with tight deadlines, resulting in enhanced stakeholder satisfaction.
QUALITY ASSURANCE LABORATORY ANALYST
Rameda Pharmaceutical Company
01.2013 - 01.2014
- Conducting tests and analyzing the results, maintaining workspaces, and preparing experiments. Performing routine, as well as non-routine, evaluation of raw materials, intermediate, and finished pharmaceutical formulations, along with packaging components, as per SOPs.
PHARMACIST
01.2010 - 01.2013
- Managed Drug and Supply inventories properly dispensed several prescriptions per day For the chemotherapy department serving different hospitals.
Education
MSc - Biomedical Diagnostics
Arizona State University
United State 01.2020 - 08.2021
Associate of Arts -
Regional Information Technology Institute
Cairo Egypt 01.2020 - 01.2020
Health And Safety Certificate -
Occupational Health And Safety Institute
Cairo Egypt 01.2016 - 01.2016
Bachelor of Science - Pharmaceutical Biotechnology
Cairo University
Cairo Egypt 01.2014 - 01.2014
High School Diploma -
Sphinx Language School
Cairo Egypt 01.2007 - 05.2007
Skills
- Project Management Software (Basecamp/Clickup and JIRA)
- PACS (Picture Archiving and Communication Systems)
- RIS (Radiology Information System)
- HIS (Hospital Information System)
- Teamwork and Collaboration
- QMS
- FDA
- MDR
- CE Mark
- ISO 13458
- FMCG experience
- Staff Management
- Change Control Processes
- Project Management
- Problem-Solving
- Computer Literacy
- Project Management Tools
- Departmental Coordination
- CAPA
- ISO 9001
- ISO27001
- Clinical Leadership
- Quality Improvement
- Healthcare administration
- Patient care management
- Medical Compliance
Languages
Arabic
Proficient
C2
English
Proficient
C2
French
Intermediate
B1
Timeline
QUALITY MANAGEMENT SYSTEM (QMS) SUPERVISOR
Philip Morris International
01.2021 - 02.2023
MSc - Biomedical Diagnostics
Arizona State University
01.2020 - 08.2021
Associate of Arts -
Regional Information Technology Institute
01.2020 - 01.2020
MEDICAL MANAGER
Sunrise Infertility and IVF center
01.2019 - 01.2021
MEDICAL PROJECT MANAGER
Flora Fusion
01.2018 - 01.2019
Health And Safety Certificate -
Occupational Health And Safety Institute
01.2016 - 01.2016
PROJECT MANAGER
Vodafone UK
01.2014 - 01.2018
Bachelor of Science - Pharmaceutical Biotechnology
Cairo University
01.2014 - 01.2014
QUALITY ASSURANCE LABORATORY ANALYST
Rameda Pharmaceutical Company
01.2013 - 01.2014
PHARMACIST
01.2010 - 01.2013
High School Diploma -
Sphinx Language School
01.2007 - 05.2007
REGULATORY COMPLIANCE MANAGER
PaxeraHealth International
2 2023 - Current
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