Regulatory Affairs Expert
Rishi Dewan is based in the UK, he has more than 8 years of experience in the Regulatory Affairs arena covering Pharma, Medical Devices and IVD Medical Devices. Rishi has a lot of experience creating Quality Management Systems to ISO 13485 and is a trained Lead Auditor.
The key expertise areas of Rishi
- CE Marking Technical Files for MDD and IVDD
- Gap Assessments to MDR and IVDR respectively.
- Creating technical files for software as a Medical Device (SaMD) working to IEC 60601, EN 62304
- Market Access and Global Registrations for China, India, LATAM, APJ as well as Saudi Arabia
- QMS including Lead Auditor and MDSAP
- Project Management
- EMA Module 3 CMC Common Technical Document for the registration of Pharmaceuticals and Electronic Common Technical Document (eCTD)
- Risk Assessment to ISO 14971:2019
Rishi also has experience compiling technical files for IVD Software as a Medical Device (SaMD) working to IEC 60601, EN 62304 which are becoming increasingly important under the IVDR. Furthermore, Rishi has gained lots of practical Market Access experience for example related to countries as China, India, LATAM, APJ as well as Saudi Arabia.
Rishi was recently involved in implementing the regulatory challenges presented by BREXIT and was the Brexit SME for the MBD Division at Thermo Fisher Scientific as well as the Senior RA Team Lead for the Market Access Team.
Rishi studied Pharmacy at the University of Sunderland and was working in the retail industry. He went back to the University of Sunderland to study MSc Drug Discovery and Development, where he learnt about drug development plus pharmacogenomics and pharmacokinetics.
Learn more about our services within Regulatory Affairs.