SFDA Regulatory Specialist - Software as a Medical Device (SaMD) / Digital Health

SFDA Regulatory Specialist - Software as a Medical Device (SaMD) / Digital Health, Saudi Arabia OVERVIEW We are a North American digital health company preparing for market entry in the Kingdom of Saudi Arabia. Our product is clinical decision support software in the pharmacogenomics field. We do not perform laboratory testing of any kind: sequencing is carried out by third-party accredited laboratories, and our software analyzes the resulting data files and produces clinical decision support reports for the prescribing clinician. We are looking for a regulatory specialist with genuine SFDA medical device and software experience to give us a clear, practical assessment before we commit to a deployment. SCOPE OF WORK 1. SFDA classification. Would our product be regulated as Software as a Medical Device? If so, at what risk class, and what does the registration pathway involve, including GHAD submission, technical file requirements, realistic timelines and official fees? 2. Authorized Representative. What are the requirements for a foreign company with no Saudi legal entity? Can a local commercial partner hold the AR role on our behalf, and what obligations, liabilities and practical risks come with that arrangement? 3. Second product. We also have a clinical decision support tool that works from a patient's medication record alone and requires no genetic test. Would it be classified differently, and is there a faster or lighter pathway for it? 4. Data residency and privacy. What are the implications under Saudi PDPL and any health-data localization requirements for processing patient genomic and medication data? Specifically, what must remain in-Kingdom, and what restrictions apply to cross-border transfer, including of de-identified or aggregated data? 5. Anything adjacent we should anticipate, for example CBAHI, national health information exchange integration requirements, or sector-specific considerations for government health systems. DELIVERABLE A written memo, roughly five to ten pages, plus a call to walk through it. We want practical and decision-oriented advice, not a literature review. Tell us what applies, what it costs, how long it takes, and what you would do first. REQUIREMENTS • Demonstrated SFDA medical device registration experience, with SaMD or digital health specifically. Please cite examples, redacted as needed. • Working familiarity with the GHAD portal and the medical device marketing authorization process. • Knowledge of Saudi PDPL and health data localization requirements. • Software and digital health focus. This engagement is not a fit for specialists whose experience is solely in pharmaceuticals, or physical devices. • Professional English. Arabic an advantage. • Willing to sign an NDA before receiving detailed materials. ESTIMATED EFFORT We anticipate ~10 hours for the initial assessment, with potential for ongoing support through registration if the fit is right. TO APPLY Please tell us briefly: your SFDA SaMD experience and a couple of examples, your view on how a foreign software-only provider typically establishes Authorized Representative arrangements in the Kingdom, and your estimated hours and rate. We will share detailed product and regulatory documentation under NDA once we have selected a consultant.