Mitesh Solanki

I drive business expansion, revenue growth, and new service offerings in the medical device industry, with deep expertise in Post-Market Surveillance (PMS) and Clinical Evaluation. With 17+ years of experience, I currently serve as a Project Manager at TATA ELXSI, Pune, where I contribute to new client acquisition, market expansion, and scaling service portfolios for existing clients, alongside delivering EU MDR-compliant programs. A key focus area of my work is advancing QARA through AI and automation.

I actively design and implement AI-driven tools and automation frameworks to streamline clinical evaluation and PMS processes, improve efficiency, consistency, and turnaround time, enhance data-driven decision-making in regulatory workflows, and enable scalable and cost-effective QARA service delivery.

Project Manager – Business and Delivery (PMS & Clinical evaluation) at TATA ELXSI (2023-06 – Present)

• Business Expansion – Exploring new business opportunities, pitching services to client, account exploration and mining, extension of new services to existing clients
• EMEA PMS Project: Leading team to update PMS documents (PMSP, PMSR & PSUR) for medical device of various classes including kick off email, pulling sales data from SAP, requesting complaint data, performing IMDRF analysis, preparing Annex – A, C, F & D, pulling registry data, literature search and drafting PSURs
• EMEA Annual Sustenance Project: Leading team to update clinical documents for medical devices (Instrument & Implants) of various classes
• Prepared client proposals, respond to RFPs, manage cost sheets & WoN allocation, and allocated resources within project budgets
• Led Annual Sustenance of Medical device for BSI Submission: Led and managed clinical documents drafting and deliveries for medical devices of various classes
• Led Annual Sustenance of PSUR drafting and deliveries for medical devices of various classes for Health Canada and EU market
• Led clinical documents drafting and deliveries for medical devices (Instruments & Implants) of various classes
• Lead author for CEPs, CERs, and SSCPs in accordance with EU MDR and MEDDEV 2.7/1 Rev. 4
• Conduct comprehensive literature reviews and appraisals of clinical data, using platforms like PubMed, Embase, and Google Scholar
• Ensure all clinical evaluation activities are compliant with global and local regulatory requirements
• Work closely with quality assurance, regulatory affairs, and product development teams to ensure clinical evaluation aligns with broader organizational and product strategies

Deputy General Manager at MYLAN RESEARCH LABORATORIES (2014-10 – 2017-03)

• Managed cross-functional project portfolios including regulatory and clinical submissions
• Oversaw vendor communications, budget tracking, and project delivery
• Contributed to product development documentation and ensured compliance with regulatory authority expectations

Project Manager & Associate Research Sci.– Toxicology at ZYDUS RESEARCH CENTRE (2004-08 – 2013-12)

• Led toxicology studies across species per OECD GLP for regulatory safety submissions
• Managed team planning, resource allocation, and documentation for preclinical development programs
• Ensured compliance with quality and regulatory systems in all study phases

Toxicology Research Assistant at TORRENT RESEARCH CENTRE (2002-08 – 2004-07)

• Executed toxicology studies in accordance with Netherlands GLP
• Supported safety assessments and report generation for preclinical programs
• Participated in cross-functional reviews and risk assessments

PMP Certification in Project Management – Project Management Institute (2026)

MBA in Pharmacology Management – Indian School of Business Management (2009)

M.Phil. in Life Sciences – Gujarat University (2002)

M.Sc. in Molecular Endocrinology & Reproductive Physiology – Gujarat University (2001)

B.Sc. in Zoology – Saurashtra University (1999)