Company : Pharmaceutical and Medical Device Company, having H.Q. at Europe & Corporate office in AhmedabadPosition : Regulatory Affairs Officer (Medical Device) Location : Thaltej (Ahmedabad) Industry : Pharmaceutical (MNC)Job Description :REGULATORY TASKS1. Gather and consolidate regulatory data related to medical device registrations from internal and external sources.2. Enter and maintain data in the company’s product data management tool, Portal of Ministry of Health, and EUDRAMEDensuring completeness, accuracy and compliance with MDR.3. Review of technical documents of medical devices in line with CE/MDR requirements.4. Verification of CE, ISO and other certificates for its authenticity with certificate issuing body.QA TASKS5. Perform desktop evaluations of manufacturers.6. Collect and assess documents needed for product approval included but not limited to product questionnaire, productspecifications, release criteria, clinical evaluation, PMS, aging studies.7. Undertake the necessary discussions with the manufacturer with reference to product range, ISO 13485/MDR complianceand product file level.8. Develop and document Standard Operating Procedures (SOPs) and work instructions to support long-term data integrityand consistency.9. Review and approval of product documentation in share point.10. Assist in review of medical device with reference to layout approval and COA review.OTHER SUPPORTING ACTIVITIES11. Assist in continuous improvement of quality management system to ensure better harmonization of pre-qualificationstatus, regulatory activities and procurement activities.12. Coordinate with QA claims, deviations, root cause, product review and retesting for medical devices.13. Coordinate with purchase and sales in any issue related to products, client/manufacturer on quotations.14. Help in training and knowledge sharing to other QD team members with current updates15. Official travel abroad as and when required.Desired Profile :Qualification : B.Pharm / M.Pharm / B.E. - Biomedical3-5 years of experience in the medical devices industry, especially in RA, QA/QC or Documentation.On hands experience with class I and II medical devicesKnowledge of ISO 13485, EU MDR, CE and other regulatory/ISO standards for medical devices.Should be able to review regulatory and technical documents such as FSC (Free sales certificate), CE, ISO certificates, DoC (Declaration of conformity), CE, IFU (instruction for use), PMS (post market surveillance), CER (Clinical evaluation report), UDI (Unique device identification), manufacturing and design control, Specifications.Good knowledge of national and international, quality management systems.Excellent verbal and written technical communication skills in English.Well structured, detail oriented, efficient with ability to follow up and communicate results.Should be able to enter a dialogue with the manufacturer for product specific evaluationContactRina Arun+91 9904322770unitedmkt@uhr.co.in