MEDICAL DEVICE QA/RA ENGINEER Graduate in Mechanical Engineering. Having, Total work experience is more than 05 years in Quality Assurance, Testing, Design and Regulatory Affairs department of Medical Device Industry. I have develop the expertise and skills in the following areas:TECHNICAL SKILLS:• Knowledge of Quality Management System certification and regulatory requirements within CE-marking.• Certified Internal Auditor for ISO 13485:2016.• Knowledge of classification of medical device according to Indian MDR 2017, MDCG 2021-24, MDD 93/42/EEC, EU MDR 2017/745 and USFDA (510k).• Faced audit for ISO 13485, EU MDR 2017/745, Ukraine Audits and CE certification for Orthopedic implants, Disposable Medical Device, Surgically products and class I medical devices.• Knowledge in relation to external supplier audits/ internal audits.• Knowledge of Eudamed Registration Process.• Compilation of Design File.• Knowledge of Testing of Medical Device.• Identify the Applicable Biocompatibility Test for Medical Device as per ISO 10993.• Prepare Device Description as per EU-MDR.• Knowledge of Post Market Surviellance (PMS) and Post Market Clinical Follow-UP (PMCF) studies.• Working Experience in the following areas: Compliance of the Regulatory Requirements, Maintaining & Documentation, Manufacturing and application of medical devices.• Solid Knowledge of Medical Device.EXPERIENCEExecutive Regulatory AffairsRomsons Group Private Limited, (9th March, 2022- To Till Present)Job Responsibilities:-• To prepare EU-MDR Technical Files (Device Classification, Device Description, GSPR, Label, IFU, Design File, Summarize Biocompatibility Reports, DOC, PMS & PMCF).• Experience in the Scope of Biocompatibility for products for EU-MDR 2017/745 Compliance.• Design Biocompatibility testing strategy to provide efficient delivery to test results for EU-MDR Compliance.• To Prepare Biological Evaluation Plan, Summary for Biocompatibility Testing Report with Physical & Chemical analysis, Gap Analysis, Toxicological Risk Assessment Reports.• To prepare the Classification of the Medical Device with Rule.• To Prepare the Device Description and Specification, Including Variants and Accessories as per EU MDR 2017/745 for Medical Devices (MDR Annex-II, Section-2.0)• Compilation of Design and Development File.• To perform ETO Sterilization Validation & other Critical Process Validation.• Support in documentation up gradation as per updated standard ISO 13485:2016, CE, MDD & MDR.• Experience working with Class III, Class II and Class I medical devices.