Jason Rich Email & Phone Number

United Kingdom

Greater London, England, United Kingdom

AI-focused role, with responsibility for regulatory compliance of AI-enabled medical device software products in markets including the US, EU, Japan, China and other regions.Responsible for developing a regulatory strategy for AIMD products and submitting applications to regulatory authorities including the FDA.Responsible for identifying and implementing.

Vienna, Austria

Responsible for global regulatory registration activities for mySugr products, as a part of Roche Diabetes Care.Post-Market Surveillance process owner.

Stockholm, Sweden

Managing regulatory projects for the registration of innovative medical device software products with regulatory authorities in the APAC region.Responsible for the coordination of global vigilance reporting, ensuring that recalls and adverse events are reported to relevant regulatory authorities (US FDA, Australian TGA, UK MHRA, etc.) as appropriate..

Stockholm, Sweden

Supported several key regulatory submissions for new products.Reviewed QMS and product documentation before approval and product release.Performed preparation work for internal and external audits to ensure the organisation was audit-ready.Monitored and followed up vigilance reporting, CAPA implementation, and internal training compliance data across the.

Reading, United Kingdom

Experience of phase I-III clinical trials, including paediatric trials.Experience in several therapeutic areas including oncology, neurology and immunology.Led the study start-up process for sites in the UK and the Republic of Ireland.Performed investigator recruitment activities during the feasibility stages of clinical trials. Utilised the Clinical Trial.

Reading, United Kingdom

Utilised Oracle Business Intelligence and Excel to develop and maintain clinical project tracking tools and generated accurate project status reports.Organised project team and client meetings: organised meeting materials, took and distributed meeting minutes.Maintained and distributed project documents, including study timelines and project.

Reading, United Kingdom

A client-facing role, assisting with the delivery of external audits to Government and public sector clients. Performed audit tests on financial statements and resolved queries with clients.