Anil Bhosale Email & Phone Number

I am currently working as a Delivery Manager for Medical Devices regulatory services and V&V. Managing delivery for 3 large medical devices customers. Responsible for portfolio worth USD 16M & 300+ team size which includes 20+ managers and program managers. Primary responsibilities includes but not limited to - Delivery Management- Responding to RFPs, proactive proposals- Providing solutions and SME support for V&V- Developing internal capabilities in Medical Devices Regulatory- Generating new business as well as extending the current business by managing the stakeholders. - Regulatory services includes but not limited to Clinical Services, DHF remediation, Risk Management, PMS, Labelling and Packaging, etc.My background:• Part time MBA (Finance) + B. Sc (Physics) with 23 years of work experience in Medical Devices industry working as Medical Devices V&V Practice Lead, Program Manager, SME Consultant (Medical Devices), Test Automation Architect, V&V in Digital Space. Certified PMP (2011-14) and Professional Scrum Master (I) • 8 years’ experience working in United States including 2 years as account manager. • Strong experience as Test Automation Architect, have designed frameworks for Desktop [Embedded device], Web, Mobile test automation for various products. Have exposure to test automation using Python scripting, VB Scripting, UFT, Squish, Eggplant, Appium, Selenium etc.• Experience designing end-2-end automation in DevOps environment using GitHub, Jenkins, Jira, etc. • Experience designing test automation unified platform, Cross platform, Cross Browser, Localization test automation that gives maximum ROI.• Rich Experience of in Verification and Validation of Class-II/ III Medical Devices development including– Cardiac Rhythm Management - Pacemakers Programmers, Insertable Cardiac Monitors (ICM), – Medical Infusion Pumps – Congestive Heart Failure - Remote HF Monitoring System, Remote home monitoring, – Radiology devices Modalities (MRI Scan & CT Scan) • Expertise in creating artifacts required for regulatory submissions with DHF, Traceability, and other Quality System Regulations of FDA, ISO 13485, ISO 14971, IEC 62304.• Experience of working with complex systems, system of systems involving Sensors, Mobile Apps (iOS/ Android), Web Applications, EHR, EMR & PACS (DICOM)• Provide SME support for Medical Devices V&V Processes, QSR, Requirement Engineering, Agile Development Processes & Tools, RM & ALM Tools.• Experience in AI/ML model validation, SaMD, SiMD.

Listed skills include Testing, Business Process, Project Management, Siebel, and 7 others.