
Donna Haire is CEO of The Eriah Group, Inc. which specializes in global regulatory, quality, clinical and medical affairs consulting services for drugs, biologics, medical devices/in vitro diagnostics, and combination products. She is a Board Member at both Sedana Medical AB, and Bioporto A/S and she is the Chief Operating Officer at FluoGuide A/S. She is a seasoned executive with over 30 years of experience in healthcare, pharmaceutical, and medical device industries. She has extensive experience in regulatory, quality, clinical affairs, operations, business development, and R&D. She has held positions as the Executive Vice President at On Target Laboratories, Vice President, Head of Medical Care Global Regulatory Affairs at Bayer, Senior Vice President of Regulatory, Quality, Clinical, and Medical Affairs at AngioDynamics and has held senior level positions at Philips Healthcare and Medtronic. She was an Adjunct Professor at the University of Akron School of Law. She is a formed Board Member of FluoGuide A/S, and served as an AdvaMed Technical and Regulatory Board Committee Member and a Board of Directors Authorized Representative. Donna Haire was designated a U.S. regulatory expert to lead multiple international trade negotiations in regulatory convergence. She has been a keynote speaker and panelist for numerous regulatory and compliance events worldwide. She holds an M.S. in Biology from Cleveland State University and a B.S. in Biology from The University of Akron.

Elisabeth is the Head of Quality & Regulatory Affairs at The Eriah Group, Inc. She is an experienced leader, business executive and consultant committed to shaping and leading global organizations in continuous improvement and innovative ways. She frequently speaks at Industry and Standards Conferences. She is a recent recipient of the NEMA Röntgen Award and the ANSI George S. Wham Leadership Medal recognizing her leadership and drive. She is presently serving on the ANSI Board of Directors and has been appointed to the Global Expert Advisory Group to Korea Ministry of Food & Drug Safety. She is also a certified auditor in QMSR, ISO 13485, MDSAP and ISO 14971 Audit Principles. Elisabeth has held senior leadership roles for more than 30 years, including executive and senior-level positions at Hewlett Packard, Agilent, and Philips. At Philips, she served as Vice President of Quality, Regulatory, Sustainability, and Product Security, as well as Vice President and Head of Global Regulations and Standards. Elisabeth holds a Bachelor’s in Science, Biomedical Engineering from Boston University and a Masters Certificate in Engineering Management from Northeastern University. In addition, Elisabeth is serving on several Boards both professional (ANSI) as well as City Government including Vice President of Central Beach Alliance Board, and Vice President, Secretary and Governance Committee Chair of Suits Stilettos & Lipstick Board of Fort Lauderdale.

Jake Haire is the Head of Marketing and Business Development at The Eriah Group, Inc. In this role, he is responsible for developing creative marketing strategies to increase new business opportunities and to establish effective sales solutions. Mr. Haire is skilled in brand development from creation strategy to usage. Your firm’s brand has its own unique purpose and story. Mr. Haire is passionate about not only defining and articulating that story, but also being the conduit between a company's brand and their audience using the latest information channels. Mr. Haire has served clients across a range of industries, including healthcare, education, public sector, and entertainment. Mr. Haire is also the CEO of Studio Eriah, LLC, a production company specializing in aerial videography, virtual production, and documentaries. Mr. Haire holds an M.S. in Film and Media Production, a B.S. in Marketing, Business Administration, and Management, and a B.A. in Integrated Media and Communications, from Ohio University.

Monika Mazur is the Head of Operations at The Eriah Group, Inc. In this role, she oversees the day-to-day activities of the company, which include budgeting, payroll, purchasing, client and contractor management, and establishing workflows to maximize the company's productivity. She started her career in education and has leveraged her exemplary communication and leadership skills to help expand both the contractor and client base for The Eriah Group. Ms. Mazur is multi-lingual, a skill that positions her well for her work managing The Eriah Group's partner relations worldwide. She has a B.S. in Education from Hiram College and an M.S. in Education from Walden University.
The Eriah Group, Inc.
Cleveland, Ohio
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