Responsibilities: Steering business strategy operations, executing strategic vision for medical devices division. Develop global scientific, Quality, regulatory and design strategies to clients, and implement compliance support. Strategic development and service expansion in medical devices consulting. Acted as a trusted advisor to C-suite executives, providing strategic regulatory and market access insights. Acted as Head of Regulatory consulting in DHF, Regulatory Submissions & Compliance, Pot Market Survilleance, Global Quality Management, IND applications. Managing and mentoring teams who are working on US FDA, EU, and APAC Product registrations, pre-submissions, and consulting for IVD, medical devices, Companion diagnostics (CDx) (Drug + IVD), and Combination medical devices (Drug + Devices). Built and managed cross-functional teams, ensuring high performance in regulatory, quality, and clinical consulting. Developed annual business plans, financial goals, and growth strategies to enhance the firm's market position. Providing strategic leadership to business teams, facilitating fruitful communication and negotiations with health authorities and regulatory bodies. Demonstrating proven track record of hands-on leadership in quality management and regulatory observance across broad spectrum of medical device activities.

Responsibilities: Developed and implemented strategies and growth initiatives to confirm sustainability of medical device consulting support. Developed annual business plans, financial goals, and growth strategies to enhance the firm's market position. Directed Global Medtech Scientific, Quality and Regulatory Solutions for in Vitro Diagnostics (IVD), Medical Devices, and Healthcare Services. Managed and optimized processes to verify smooth execution of projects, including monitoring CSAT, key metrics, CAPA, and driving continuous augmentation. Provided guidance and oversight for 10 medical device D&D design and development projects, establishing lab capabilities for testing, design verification, and validation of EMC devices and SaMD.

Responsibilities: Supervised Global Medtech Regulatory Solutions, Clinical trail applications, Post market surveillance – Vigilance, Quality management to IVD and Medical Device clients. Build and maintain strong relationships with medical device manufacturers, startups, and investors in QA & RA. Build and maintain strong relationships with medical device manufacturers, startups, and investors. Oversaw and completed 30 projects across 38 countries for IVD/MD clinical investigation study submissions to Ethics Committees and National Competent Authorities. Ameliorated process dexterity by creating tracker for communication responses from Regulatory Authorities, Notified Bodies, and follow-ups on clinical studies, including Companion Diagnostics (CDx) and IVD products. Reviewed regulatory documentation for final submission packages for 15 products, developing strategic plans and providing guidance on registration activities. Provided leadership in creating and developing5key strategic customer relationships, strengthening connections with both existing and prospective clients. Built and maintained an extensive services catalogue, incorporating latest technologies for global healthcare projects. Directed and superintended 3 medical device design and development projects in EU and USA, establishing lab capabilities for testing, design verification, and validation processes. Effectively managed and supervisied HEOR reports, real-world data (RWD) landscapes, real-world evidence (RWE) of pharmaceuticals and medical devices. Responsible for overseeing development, review, and approval of SOPs, Work Instructions (WIs), global biologic/device regulations, and Good Clinical Practices (GCP), ensuring strict compliance. Implemented 35 Standard Operating Procedures (SOPs) for medical devices and IVD devices, along with 50 work instructions, reducing escalating quality concerns by 60%. Collaborated with client cross-functional teams to manage clinical trials, ensuring regulatory compliance and achieving success rate of over 90%.

Responsibilities: Subject Matter Expert, and led teams of in Medical devices, Vitro Diagnostics (IVD) Scientific, Quality, regulatory projects particularly for MDR, IVDR compliance Developed and maintained integrated project schedules, budgets, and resource allocation plans using MS Project. Drove continuous improvement in program governance, reporting (via dashboards/KPIs), and stakeholder communication. Review of V&V validation documents and recommend changes or fulfillment of critical documents, such as Dossiers, Stability, Labelling, design documentations, and manufacturing documenations to comply with regulatory requirements. Controlled and victoriously completed over 50+ technical files for IVDR Key stake holder in establishment of Center of Excellence (CoE) for IVD & Medical Device Regulatory Services, overseeing performance testing for 5 products and implementing automation services for 2 clients, Benchmarking studies. Supported global healthcare quality and regulatory compliance for Digital Health products, including SaMD (Software as Medical Device) for both FDA and EU markets Conducted training for team members on regulatory requirements and Quality Management Systems (QMS); reviewed and guided development of policies and procedures

n Dickinson India Pvt Ltd, Hyderabad Responsibilities: Subject Matter Expert in developing scientific and clinical pathways for in Vitro Diagnostics (IVD) products, including MALDI spectroscopy and blood culture IVD tests for clinical laboratories, hospitals, and research institutions Performed business analysis and market shaping strategies, driving 15% increase in business YOY by identifying market opportunities, setting pricing strategies, forecasting, and evaluating product potential Built network of 200 Key Opinion Leaders (KOLs), customers, and industry experts to support product registration, approval processes, market positioning, and promotion Organized, led, and participated in 30 medical and scientific meetings, conferences, RTMs, and roadshows focused on health and IVD Developed strategies for product launches, post-market surveillance, customer mapping, competitive intelligence, and network-building initiatives Created and executed Clinical Development Plan for business, adapting product positioning concepts to align with market needs.

Responsibilities: Inspected and provided bench support for manufacturing of 300 antibodies and antigens for In Vitro Diagnostics IVD and Research Use Only (RUO) applications Design of experienments led upstream and downstream scaled up and produced 50 new recombinant antibodies Designed 36 immunogens, 50+ primers, and completed 55 Antigens, proteins using preparative chromagratophy techniques, and validations. Large scale purified 8 polyclonal antibodies for IVD Kits with >90%, followed by ELISA, Flowcytometry analysis and method validations. Created and Reviewed all manufacturing SOPs and batch records for finished goods, initiating and closing CAPAs related to manufacturing processes and audit findings Implemented best manufacturing practices, resulting in 20% improvement in productivity, 33% reduction in waste, and $500K in cost savings through techniques like JDI, Kaizen, Pareto Priority Index (PPI), and Lean Manufacturing methods Supported revenue growth by identifying new manufacturing opportunities Additional roles: Member of Internal Audit Team, 5S, Emergency Response Team ERT, and Safety Committee. Scientist - R&D | Vimta Labs Limited, Hyderabad Responsibilities:

Molecular diagnostics IVD projects development, completed 12 Gene Cloning, Expression of target genes in Mammalian and E.coliexpression systems, purification of recombinant proteins for diagnostic, drug discoveryprojects Worked with Business development teams in Training, Initiate new project proposals,interacting with the customers and updating the project status. Lab set up completed for cloning, expression, protein purification, cell culture in 9months. Prepared of 43 SOPs, made sure 100 % funcational by maintenance of lab equipment,maintain to keep Lab note books. Responsibilities: