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 AI-related process updates across the organisation in accordance with regulatory requirements from key markets.

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. Planning and participating in internal and external audits (including unannounced inspections).Preparing for upcoming changes to regulations and requirements (MDR, MDSAP) and assisting with the identification and implementation of necessary QMS changes within the organisation.Applying knowledge of ISO 13485, QSR, Chinese GMP and Korean GMP and other global requirements for medical devices.

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 organisation.

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 Management System (CTMS) to track investigator recruitment activities.Performed essential document collection, review, maintenance and close-out activities. Ensured that study conduct complies with applicable local regulatory requirements and ICH-GCP guidelines.Supported investigators and investigative staff in fulfilling obligations related to local submissions in accordance with local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements, in both the UK and the Republic of Ireland.Performed study tracking via CTMS (and/or sponsor applications) to ensure that the study files were current, accurate and complete.Documented site and sponsor contact and study interactions in a timely and professional manner.Assisted with resolution of site/data queries.Liaised with project team members regarding study site issues.Provided quality review of the informed consent template.

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 plans.Dispatched investigator and pharmacy site files.

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.