Signed in as:
filler@godaddy.com
Meet The Team
Andrea Dwyer Steiner-Founder and CEO
Whether developing a new product that requires a detailed and nuanced regulatory strategy or navigating regulatory compliance, Andrea Dwyer Steiner of Medlogics International LLC is whom you want in your corner. Andrea's expertise in the Regulatory Affairs profession spans two decades. She is a consummate learner, who believes in continuing education and the need to stay abreast of both industry and regulatory changes, allowing her to achieve more for her clients than she did the week, month, or year before.
Andrea’s passion for Regulatory Affairs was sparked after spending summers as an INROADS intern at Cordis a then, Johnson & Johnson Company. She always had an interest in science and biotech research and initially considered a career in pharmaceutical drug development. Andrea's time at Cordis provided exposure to the Research & Development field, specifically for a drug eluding stent. As a Regulatory Affairs intern, Andrea had the unique opportunity to observe product development first-hand Since then, Andrea has garnered experience in the Regulatory Affairs Field and dealt with various product lines. These include:
· Orthopedics, both implantables and accessories
· SaMD, including robotics.
· Analytical Assays
· Invitro diagnostic (IVD) Products
· Electrosurgery Devices
· Women's Health Products
· Cardiovascular & Endovascular Devices
· Implantable Pulse-Generators (IPG) Biologics
Andrea’s clients describe her as a problem solver and team player who is industrious, knowledgeable, ambitious, and thorough. With these attributes and decades of experience, there is no doubt you can trust Andrea and her team to develop innovative and creative regulatory strategies that result in domestic and international regulatory approvals.
Yvonne Bete-Regulatory Affairs Associate
We are thrilled to introduce Yvonne Bete, a talented Regulatory Affairs Associate who came to Medlogics with 25 years of experience in the nursing field. With her unique combination of regulatory expertise and nursing experience, Yvonne brings a comprehensive perspective to our team, ensuring the highest standards of regulatory compliance for our clients in the medical industry.
Her firsthand experience in patient care, medical procedures, and healthcare systems enhances her ability to navigate complex regulations and streamline the regulatory process for our clients. With her attention to detail, meticulous approach, and deep understanding of medical practices, Yvonne is dedicated to ensuring the safety, quality, and effectiveness of medical devices throughout their regulatory journey.
Zachariah Lee-Business Operations Manager
We are delighted to introduce Zachariah Lee as the Business Operations Manager at Medlogics International LLC, bringing a diverse skill set that combines business operations and Information Technology (IT) expertise. With his exceptional leadership abilities and technological acumen, Zachariah plays a pivotal role in optimizing our operational efficiency and driving strategic growth.
Zachariah's background in both business operations and IT enables him to bridge the gap between technology and operational effectiveness. His proficiency in leveraging innovative IT solutions to streamline processes, enhance productivity, and improve overall organizational performance has made a significant impact at Medlogics. With his strategic mindset and strong business acumen, Zachariah ensures seamless operations across various departments, empowering our team to deliver exceptional services to our clients.