Navigating the complex world of medical device regulatory affairs requires expertise, precision, and up-to-date knowledge. Featured.com presents a curated directory of top medical device regulatory experts, offering invaluable insights on FDA compliance, international regulations, and emerging trends in medical technology. These seasoned professionals have been featured in leading industry publications, sharing their expertise on topics ranging from regulatory strategy to quality management systems. For publishers and journalists, our directory provides quick access to authoritative sources for articles on medical device regulations and compliance. For regulatory affairs professionals, it's an opportunity to showcase your expertise and connect with major media outlets seeking expert commentary. Whether you're writing about new FDA guidelines or global market access strategies, you'll find the perfect expert here to elevate your content. Explore our directory to connect with trusted medical device regulatory specialists and enhance your next article or project.
Showing 20 of 186 experts
Regulatory Solution Services at Regulatory Solutions India
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:
Corporate Compliance Expert at Ceribell, Inc
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.
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Healthcare Development Expert at Vention
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.
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QA/RA Director at Comply Guru
Co-Founder & CEO at OurRecords, Inc.
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.
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Sr Engineering Manager at Medable Inc.
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.
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Co-founder at Medicai
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.
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Principal Investigator at Parameters Research Laboratory
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Clinical Trials Optimization Expert
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.
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Operations Manager at The RegTech
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.
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Global Diversity, Inclusion & Equity Executive Council and Awards Leader at Medtronic, PLC
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
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CRO at Fictiv
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!
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Engineering Manager, Latam at Vicarius
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.
RCIC-IRB at NNC Immigration Services Inc.
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Principal Recruiter/Recruiting Operations Improvement (ROI) at Cayuse, LLC
I am open to relocation. Looking for Lead Recruiting/Executive Recruiter roles that will utilize my skills in Executive/Specialty Recruiting/TA/Operations. I have a high-level consultative approach to help companies improve their processes utilizing current and past data all while ensuring the best candidate and internal customer experience. I am one that does not let grass grow under my feet and am a “get it done” person. I thrive in companies where we can learn and grow and cheer each other on to be successful. No impediments to being granted Government security clearance.
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SQA Engineer at Antares Tech
Experienced Software QA Engineer with over 5 years of expertise in software testing, specializing in high-quality software delivery through meticulous test planning and execution. Proficient in various testing methods for web and mobile applications, and skilled in analyzing user requirements and developing comprehensive test strategies.
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Director at LOLER Examinations
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President & CEO at CME Corp.
I always look for ways to improve our customers experience and also at the same time how to make our employees enjoy their work experience. Happy employees make happy customers and visa versa. We spend so much of our time at work that we need to be happy there, if you are not, find that place.
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Senior Directior, Revenue Operations at Paro
I am a passionate, data-driven problem solver, focused on discovering and understanding customer decision-making moments. My skills bring those key insights to the forefront through radical transparency, data analysis, and storytelling. I succeed with best-in-class technology, exhaustive repetition of failure, and a team of rebel thinkers.As I have developed my leadership principles and approach, I've formulated my mantra: Leaders manage results, not time. Let your team develop their path to success; the leader's role is not to be a radical dictator."SPECIALTIESBusiness OperationsRevenue EnablementGo-to-Market StrategyData Analytics Channel Marketing Marketing Automation
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Systems Compliance Manager
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Showing 20 of 186 experts
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By joining Featured.com, medical device regulatory experts can expand their professional visibility and connect with top-tier publishers seeking expert insights. This platform offers opportunities to share knowledge on crucial topics such as regulatory compliance, CE marking, 510(k) submissions, and emerging trends in the medical device industry. Experts can showcase their expertise, potentially leading to media features, speaking engagements, and collaborative opportunities.
Publishers often seek expert commentary on a wide range of medical device regulatory topics, including recent changes in regulations (e.g., EU MDR implementation), global harmonization efforts, cybersecurity requirements for connected devices, unique device identification (UDI) systems, and regulatory challenges for innovative technologies like AI in medical devices. Experts may also be asked to provide insights on regulatory strategies for different device classifications or navigating the complexities of international market access.
Featured.com utilizes a sophisticated matching system that aligns publishers' specific needs with the expertise of medical device regulatory professionals in our network. The platform considers factors such as the expert's specialization areas (e.g., in vitro diagnostics, software as a medical device, or combination products), regulatory experience in different markets, and track record in providing media commentary. This ensures that publishers can connect with experts who have the most relevant knowledge for their particular story or inquiry.
Featured.com offers access to a diverse range of medical device regulatory experts, including regulatory affairs specialists, quality assurance professionals, clinical evaluation report (CER) writers, and regulatory strategists. These experts have in-depth knowledge of FDA, EU MDR, IVDR, and international regulations, covering various aspects of the medical device lifecycle from pre-market approval to post-market surveillance.
Join our network of professionals and connect with journalists and publishers looking for your expertise.