Job Title

Role - Delivery Manager- QARA Experience: 15 to 20 Years Location: Bangalore /Mysore Notice period: Immediate to 30 days preferred Mandate Skills: Electromechanical devices, IEC 62304, ISO13485, ISO14971, IEC 60601-1, FDA, EU, Lead Auditor, SaMD Delivery manager exposure Job Description: Provide leadership and direction to the Quality Assurance and Regulatory Affairs team. Application of design controls. Knowledge and experience in Quality Management System (ISO 13485, ISO 9001, MDSAP) in line with Corporate, Business Unit, and local requirements. Compliance knowledge with EU IVDR 2017/746, EU IVDD 98/79, ISO 13485, MDSAP, ISO 9001, China MDR, ANVISA and USA 21 CFR part 820 Experience in conducting internal audits and supporting external & regulatory audits (FDA inspections) within the designated area of responsibility. Engage with Global and commercial Regulatory teams to ensure regulatory activities are in alignment with business requirements Experience with Supplier Quality Function to drive supplier quality at plant and Business Unit level. Conduct Supplier Audits by Quality Assurance Agreements. Contribute actively to defining IVD documentation, from user needs and applicable standards, to design verification testing, and give appropriate guidance to the development teams Collaborate with QMS and regulatory specialist /managers /process owners in overseas offices (United states, Europe, China and other countries) Review and provide regulatory impact assessments for product design changes (Reagent, Instruments and Software) Creates and maintains Technical / Regulatory documentation (EU IVDR, EU IVDD 98/79/ec), US FDA 510 (k) submissions, and China Submissions (Software & Instrument& Reagent) and tracks the status, and progress of regulatory documentation Work closely with Clinical Affairs to set up quality files suitable for submission to pre-market clinical investigation as required by Competent Authorities Work in collaboration with the Legal team to prepare manufacturing and quality agreements with external providers and suppliers