Ramesh Kumar Soni Email & Phone Number

Agra, Up, In

Agra

MEDICAL DEVICE QA/RA ENGINEER Graduated 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 developed the expertise and skills in the following areas:TECHNICAL SKILLS:• Awareness 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.• Knowledge of ISO 10993 Series of standards.• 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 QA/ RARomsons Group Private Limited, Agra (9th March, 2022- To Till Present)Job Responsibility:-• 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.

Agra, Uttar Pradesh, India

EXPERIENCEExecutive Regulatory Affairs9th March, 2022- To Till Present• Experience in the scope of Biocompatibility for products for EU-MDR 2017/745 Compliance.• Knowledge of Chemical Characterization and Toxicological Risk Assessment.• Knowledge of ISO 10993 Series of standards.• Design Biocompatibility testing strategy to provide efficient delivery to test results for EU-MDR Compliance.• Prepare Biological Evaluation Plan, Summary for Biocompatibility Testing Report with Physical & Chemical analysis, Gap Analysis, Toxicological Risk Assessment Reports.• Preparation of 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.• 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.• Maintaining regulatory documentation database for the EU-MDR as well as rest of the country.• Ensuring compliance with all regulatory standards and guidance requirements.• Assisting with the preparation and review.• Communication with other department i.e. R&D, Design & Development, Quality Control, Quality Assurance, QMS, Moulding & Extrusion.• Communicate with third party and different Unit of the company.• Participate in Internal Audit and prepare Internal Audit Checklist (Logbook).

New Delhi, Delhi, India

Regulatory Affairs-ExecutiveFeb 2021- March 2022• Knowledge of Eudamed Registration Process.• Knowledge of Medical Device Labeling requirement.• Knowledge of Unique Device Identification (UDI).• Knowledge of Complaint handling and Product investigations of medical devices.• Knowledge of CAPA Management.• Awareness of Ethylene Oxide Sterilization process and Cleanroom Validation.• Search relevant / revised & new guidelines or standard/s (National/International/Device Applicable Standard) & Prepare Gap Assessment as required.

New Delhi, Delhi, India

QA/RA ENGINEERFeb 2019- Jan 2021• Knowledge Preparation of DOC/ COC/SDOC.• Prepare Artwork: Preparation of NPD (New Product Development)- Label, IFU etc.• Knowledge of Medical Device Labeling requirement.• Product registration export /Tender & empanelment documents Update the list of documents & list of records.• Artwork development and controlling of orthopedic implants, general medical devices and packing material.• Provide responses to regulatory agencies regarding product information or issues.• Maintain all regulatory Agency Submission documents and analysis.• Preparation and submission of regulatory agency applications, reports or correspondence.• Preparation and submission of regulatory agency applications, reports or correspondence.• Ensuring QMS is adhered to and followed in all departments.• Ensuring applicable and current documentation is available to all personnel.• Checking good documentation practices are followed.

Bachelor Of Technology - Btech, Mechanical Engineering, A

Bachelor Of Technology - Btech, Mechanical Engineering, 72%

Activities and Societies: Medical Device QA/RA ENGINEER

Bachelor Of Technology - Btech, Mechanical Engineering, 72%

Activities and Societies: Project- Four Wheel Auto Steering Adjustment Cur• • Currently working in Romsons GROUP PRIVATE LIMITED as Junior.

Bachelor Of Technology - Btech, Mechanical Engineering, 72 %

B. Tech, Mechanical Engineering, 72%

Activities and Societies: INDUSTRIAL VISIT & TRAININGS 4 WEEK SUMMER TRAINING IN NTPC DADRI • I have done indrustial training in BOILOR.

Intermediate, Science Branch ( Physics, Chemistry And Mathematics)