Recognized Medical Device Regulatory Experts Leaders 2025

A post-graduate in Pharmaceutics from Mumbai University with over 25 years of Regulatory Affairs experience across leading Pharmaceutical and Medical Device organizations. Managing Regulatory affairs is my core strength and in addition I have a rich experience in handling quality compliance, clinical trials, patents and scientific information. In 2011 I started with my own venture - Regulatory Solutions India for providing Regulatory Affairs consultancy with a motto to build 'bright bRight strategies' to organizations . Regulatory Solutions India provides RA services to the Medical Device/Pharmaceutical/ Cosmetic Industry, which include:1) Regulatory Strategy Development 2) Consultancy services from application submission to Product Approvals/ Licenses comprising:

I’m a lifesciences compliance strategist with a passion for building real-world, right-sized programs in fast-moving environments. With deep experience in pharma and medtech, I specialize in translating regulatory complexity into practical, actionable frameworks. I’ve spent 7+ years navigating the gray areas of compliance—from training physicians on industry expectations to building startup programs from the ground up. I believe compliance should be ethical, functional, and human-centered—and that culture is built through clarity, storytelling, and respect, not fear. Outside of policy and audits, I speak regularly on startup compliance and love turning “boring” topics into memorable moments. I'm here to connect, create, and contribute.

For approximately the last 30 years, I have worked within and with organizations to help them to address the challenges presented by climate change and sustainability. Frustrated by the unnecessary complexity in these areas, my mission is to simplify the complex for the greater environmental benefit and provide cost effective solutions to help organisations on their sustainability journey. My understanding of regulations, their direction and evolution has enabled me to simplify this complexity and influence company strategies to ensure the risks presented are managed and the potential of new opportunities realized. My knowledge across a broad spectrum of sustainability regulations and carbon markets of the UNFCCC, EU ETS, and domestic schemes in the UK, US, Kazakhstan, Korea, China and and sector specific schemes such as EU MRV, UK MRV and IMO DCS, enables me to advise both global and local players, on all sustainability issues wherever they are. I relish opportunities to design regulations, guidance, standards, schemes, and management systems and in understanding and implementing approaches and tools for them for business benefit. I have helped governments and organisations work through the maze of technical, operational and commercial issues that must be navigated to realise the opportunities of new regulatory requirements in these areas. I am privileged to have written for leading publications and speak on climate change and sustainability subjects at a variety of events. I have also designed and delivered tailored workshops and training courses on numerous subjects including: Extended Producer Responsibility, Recyclability Assessments, Environmental Auditing, Environmental and Energy Management Systems, Carbon Footprinting, Net Zero approaches, Verification, CSR, EU ETS, MRV and Electricity Capacity Markets for specific organizations, governments and business groups. I pride myself on my ability to simplify the complex and provide understanding where there may be confusion.

Experienced Delivery Manager with a proven track record in managing and delivering custom software development projects. Skilled in coordinating cross-functional teams, optimizing workflows, and ensuring project milestones are met within budget and timelines.With over 15 years of experience, I have successfully led projects in diverse industries, focusing on creating tailored solutions that meet client needs and drive business value. My expertise includes stakeholder communication, resource planning, and risk management, all backed by a strong technical foundation.I thrive in dynamic environments, where I can apply my leadership skills to foster collaboration, enhance team performance, and deliver exceptional results. Currently exploring opportunities to contribute my skills to impactful projects in technology-driven sectors.

Bill Hall is the Cofounder and CEO of OurRecords, where he leverages over 30+years of experience in the technology and compliance sectors to create innovative solutions that streamline regulatory compliance management. His unique blend of technical expertise and deep knowledge of industry regulations has been pivotal in developing tools that simplify complex compliance processes, earning OurRecords a reputation as a trusted industry leader. Bill holds a Computer Science Degree from University of Louisiana Lafayette and has previously held key executive leadership roles in healthcare and other industries, where he developed a keen understanding of the challenges faced by organizations in highly regulated industries. His commitment to excellence and forward-thinking approach continue to drive OurRecords' growth and success.

Zaeem Chaudhary, MCIAT, is the Director of AC Design Solution, a multidisciplinary architectural and engineering practice in London. He has delivered over 10,000 residential projects the UK. His expertise covers architecture, structural engineering, building regulations, and party wall services. Zaeem specialises in making complex alterations stress-free for homeowners and developers, with a focus on extensions, loft conversions, and structural modifications.

Over 16 years of leadership, management, development, and engineering experience including Certifications in Project Management, CSM (Certified Scrum Master), and knowledge of advanced technologies and design principles. Specialties: * Experience and proven success in managing complex & multi-phased projects, cross-functional teams, Products * Building high-velocity Engineering teams * Proven ability to improve employee engagement, productivity, and retention by establishing a healthy work culture, processes & practices * Effective communication and excellent Technical, Analytical, and presentation skills * Maintain an effective balance between Big-Picture and strategic thinking and focus on details necessary for project execution * Experience working and delivering high-scale solutions with varied tech stacks and databases such as Java, Sprint, hibernate, SQL and non-SQL databases, big data technologies, and cloud technologies such as AWS.

Serial Technology Entrepreneur with 15+ years of experience. Forbes 30 under 30. I enable innovation through technology in fields like healthcare, education, and finance. I love life, new experiences, new places, and meeting new people. I am a strong believer in loving what you do. I believe in Karma and a pay-it-forward mentality. I tend to be very optimistic and look at life’s events from a positive perspective.

Cynthia Udoka Duru has led innovative projects across various sectors, from driving cloud-native system design, automated CI/CD workflows, and infrastructure lifecycle management to architecting solutions, contributing to digital health, finance & maritime cybersecurity, enabling exponential growth, improving infrastructure efficiency, and supporting award-winning innovation across Africa and Europe.

In my role, I meticulously oversee various clinical projects, ensuring each phase is executed with precision and in compliance with GCP standards. Core Competencies: Clinical Trials Monitoring Clinical Safety Protocols Streamlined Clinical Operations Regulatory Compliance Mastery Educational Background: MSc in Molecular Science and Nanotechnology, Louisiana Tech University MSc in Medical Genetics, MGM University of Health Sciences With a robust educational foundation and a keen eye for detail, I have successfully navigated through different therapeutic areas and regions, delivering high-quality results consistently. My journey in the realm of clinical research is driven by an insatiable curiosity and a deep-seated commitment to advancing science and practice. Let’s Connect! If you are passionate about transforming health care and improving patient lives, or if you wish to exchange insights and collaborate on projects, feel free to connect with me. Together, let’s contribute to a healthier, more understanding world for individuals navigating through challenges.

Igor Ujhazi is a seasoned expert in digital governance, regulatory technology (RegTech), and public sector innovation. With a background in leading global digital transformation initiatives, he specializes in e-government, digital fiscalization, AI integration in tax and customs administration, and sustainable governance strategies. Igor serves as Chief Executive Officer at The RegTech, a company based in Dubai UAE and focused on delivering tailored, cost-effective digital solutions for governments, particularly in emerging economies. He is also an alum of the Transatlantic Inclusion Leaders Network and an advocate for equitable digital access through pragmatic, policy-driven innovation.

Award-winning global human performance accelerator. Extensive depth of expertise implementing world-class learning solutions leading to tangible retention, diversity, and performance results. Recognized for consistently exceeding expectations, unmatched strategic thinking agility, and impressive track record of building high demand programs. Directly created and influenced renowned programs to support leadership diversity initiatives. Broad human resources expertise including: talent development, compensation & benefits, and diversity & inclusion. I am known for my transparent, visionary leadership style and talent for building alignment to support organizational goals. Additional Competencies: Strategic HR Planning | Implementation Change Management | Organizational Development People Strategy | Talent Management Process Improvements | HR Operations Workforce Planning | Implementation Performance Management | Succession Planning Employee Engagement | Employee Relations High Performance Team Building | Leadership

Proud family woman and go-to-market executive helping Fictiv deliver the future of manufacturing today! Fictiv simplifies sourcing for our customers in a world of economic and global supply chain uncertainty. Our intelligent platform, global network of Fictiv partner factories and amazing employees help small and large enterprises get hardware products to market 40-70% faster, help our customers expand gross margins by reducing COGS st least 20% and provide access to some of the best supply chain managers, engineers, quality experts, logistics and export experts when good talent is hard to find or too expensive. To date, Fictiv has delivered more than 30 million parts to 3,300 different companies from our locations in the U.S., Mexico, China and India to help engineers and sourcing managers from prototyping to pre-production to production with the best speed and quality all at the right price!

As a Cyber Security Specialist and Engineering & Enablement Director at Vicarius, I lead pre-sales and solution architects in cybersecurity, overseeing customer success engineering and product improvement. I also manage enablement activities in Latam, developing new training materials and ensuring top-notch training and preparedness. With over 20 years of experience in cybersecurity, I hold certifications such as CISSP and CCSK, demonstrating my expertise in information security and cloud security knowledge. I am passionate about driving innovation and enhancing cybersecurity solutions from customer requests.

I have over all 17+ years’ experience in Product Design with Caterpillar, CNH Industrial (CNH) and AGCO Corporation (GSI). Responsible for New product Design, Current Product Design, shop support, manufacturing quality issues and supplier follows. Products: Valve train Components, Underground Mining, Motor Grader, wheel loader, Forest products, Industrial waste machines, Tractor loader, Combine Harvester, Grain systems & Fast Fuel systems.Skills: Proficient in Pro/E Creo 7.0 (Part & Sheet metal modeling, Pro-Piping, Large Assembly Management, Drawings using ASME Y 14.5M-1994), Shop floor support, Manufacturing & quality support, Tool & Fixture design, Teamcenter, APQP, DFEMA, Aftermarket, SAP-MM, Epicor and Project management.