Regulatory SubmissionsEUDAMED Registration510k SubmissionISO 14971 Risk managementPMS, PMCF, PSUR, Clinical EvaluationGTIN Generation (GS1 Kart) | Basic UDI-DIMAUDE, MHRA Database, GUDIDTechnical DocumentationQuality Assurance (ISO 13485 implementation)

-Responsible for QMS implementation ISO 13485:2016, ISO 10555-1:2009, 10555-3:2016, 9626-2016, ISO 11070 etc. - Continuous improvement QA processes and procedures. - Review of SOP's, WI and SPF and check for updates. - Responsible for Certificate of analysis, BMR, and CAPA, & Declaration of conformity.- Responsible for compliance as per medical device regulations (MDR). - Preparation and Responsible for COA, COS & COC. - Responsible for Stability studies (Accelerated and Real time Study at 35° and 5°C). - Responsible for FG and analysing the process through verification.- Analytical methedology of the Products.- Preparing and responsible for Process Validation.- Responsible for Master Formula Record.- Responsible of QA Documentation- Preparation of documents for submission to FDA. -Having a strong background in lab work/research work in DNA extraction/isolation, Photochemical testings, electrophoresis, SDS-PAGE, Soxhlet apparatus, Prep of serum from blood and willing to learn more in this field.

Responsible for the research, positive result and thesis on phytochemical and antioxidant activities in Murraya koenigii and their benefits for diabetes and cancer patients where soxhlet appratus, curry leaves and methanol were used.

Molecular biology lab techniques