Shery Makram

Part-time quality and regulatory affairs consultancy for a UK medical device regulatory consultancy.

- Author monthly regulatory insight articles on UK and EU medical device regulation for the consultancy's website and LinkedIn audience
- Produced a research brief analysing the MHRA's draft Medical Devices (Amendment) Regulations 2026
- Review post-market surveillance reports in support of cl

Project-based independent advisory engagement, retained by executive leadership after two and a half years with the company.

- Authored a brand evolution strategy adopted by executive leadership, covering market positioning, visual identity, and phased rollout across digital, fleet, and physical assets
- Evaluated an inbound device supply partnership from one of Egypt's leading private hospital

- Conceived, budgeted, and hosted a 10-episode Arabic-language medical education YouTube series reaching approximately 550,000 combined views, with clinical accuracy oversight across all episodes
- Built the programme's production budget of approximately EGP 1.5 million as a self-initiated proposal, mapping cost against projected reach and brand trust returns
- Managed a 7-person team across opera

Coordinated the centre's medical device programme, including its respiratory device (CPAP/BiPAP) portfolio, alongside full-time employment at Novartis.

Embedded within the oncology medical affairs function, supporting programme delivery for Lutathera and Pluvicto in a compliance-critical, matrixed environment where GCP adherence, risk oversight, and cross-functional coordination are central to the role.

- Maintained ICH-GCP compliance across all programme workstreams: TMF quality, AE reconciliation, and documentation standards, with zero audit

First substantive industry role, coordinating regulatory submissions and international partnerships for a respiratory device manufacturer, with direct exposure to FDA, CE Mark, and international trade environments.

- Independently identified and approached distributors in emerging markets, closing 4 international partnerships across Tunisia, Ukraine, Libya, and Morocco
- Served as the company's

- Maintained complete audit compliance across QC documentation and analytical workflows, achieving zero major findings during internal and external inspections.

- Applied standardised QC protocols consistently across all analytical outputs to ensure data accuracy and reliability for downstream regulatory use.

May 2026 · Expires May 2028

Dec 2024 · Expires Dec 2027

Jul 2022

During my MSc, I delved into the core principles of Functional Neuroanatomy, Cellular and Molecular Neuroscience, and Computational Methods for Brain Sciences. I enhanced my expertise with optional modules such as Addiction and Neuropharmacology in Psychiatry, Machine Learning in Neuroscience, and Brain Imaging techniques. My research project focused on conducting a meta-analysis on the efficacy o

During my BSc in Biomedical Science, I developed a comprehensive understanding of molecular biology, biochemistry, and human physiology, with hands-on experience in laboratory techniques such as PCR, electrophoresis, and cell culture. I explored key areas of biomedical science, including immunology, genetics, and pharmacology, to deepen my knowledge of disease mechanisms and therapeutic interventi