Working at GMED

I am Laetitia Marzi, Certification Project Manager at GMED North America. I have always been driven by curiosity and creativity. First drawn to research, I then decided to join GMED to discover the not so well-known world of medical device regulation.

Before placing their devices on the market, medical device companies may need certification to provide evidence that their devices are safe for the patients they are destined for. As a notified body Certification Project Manager, I am in charge of medical device companies’ entire certification projects and responsible for the planning, execution, and completion of their certification projects. I interact with all stakeholders, analyze, and present audits or reviews results and participate in the certification decision.

GMED North America’s best asset is its people; they are knowledgeable, supportive, and reliable. I always feel supported and helped here.

People looking for teamwork combined with individual analysis tasks and intellectual stimulation within a great culture will find it at GMED North America

My name is Dharmendra Thakur. I have an engineering background in material science and metallurgy and have completed my master’s degree in business administration and environmental science and technology. I have more than 20 years of working experience in manufacturing industries (rolling mill, tube mill, wire drawing and cable, extrusion, forming, heat treatment, foundry, ore dressing and medical devices) in the field of quality and 10 years in government and the service industry in the field of regulatory and management. I have visited many places in and around Nepal (my birthplace), India Pakistan, the Netherlands, Belgium, France, the U.K., Switzerland, and many parts of the USA. I like gardening, spending time with loved ones, and watching movies and TV shows in my leisure time.

I joined GMED NA in 2014 as a Certification Project Manager and am currently working as a Lead Auditor and Product Reviewer for medical devices. My favorite things about GMED NA are UNITY in DIVERSITY and teamwork. I work at GMED NA because I have a passion for quality and regulation of medical devices, which stems from my past professional experiences. We have a family environment that drives us to achieve personal and professional objectives.

“Hello, I’m Alexa Sanchez! I am the processing manager for GMED NA and have worked with the company for a little over three years.

When I first joined the team in September 2019, I started as an Operations Coordinator in a temporary capacity. Afterwards, I became a full-time coordinator in 2020, working on offsite/onsite audit service planning and audit committee planning. In March 2021, I was promoted to Processing Manager, and continue in this role. In the processing department, my team works alongside the project managers on all aspects of the certification process and aim to get our clients’ certification in a timely manner.

I am driven by my love of learning, and I enjoy working at GMED NA because I can use creative thinking to solve problems that support my main mission; to empower, support, and facilitate my teams’ endeavors. I am grateful to work alongside colleagues that share their wisdom if you need, and the spirit of collaboration we share.

When I am not working, you can find me studying, swimming in the nearest body of water or dancing salsa”

“My name is Adam Barlett, and I am a Certification Project Manager and have recently started the process to become a Product Reviewer. My education and background focused on engineering and orthopedics. I have been working for GMED since August 2021 and before that, I spent about 7 years in product development for orthopedic devices. When I am not working, I like to spend my time focusing on my close family and friends. I am an avid gamer and I also like to spend my free time practicing many creative projects like oil painting, 3D sculpting, and woodburning.

My favorite thing at GMED is working in a group that has an immense amount of collective knowledge. The backgrounds of everyone at the company are very diverse, and because of this, there is always an opportunity to learn. I think some of the main reasons to work at GMED NA are the diversity of people at the company and the flexibility of the work environment. There is always someone who can teach you something new, which is great for career development, and the flexibility of the work environment leads to great balance for me.”

Chris is a Biomedical Engineer with a MSc degree from the University of Virginia. His undergraduate degree is in Materials Engineering with a Minor in Biology. Chris has always had an interest in biomaterials and applies his knowledge routinely in his role at GMED. He also has expertise in the area of Clinical Evaluation for medical device CE Marking, and is a frequent author, speaker, and trainer on the subject. With over 15 years of experience in the area of European medical device regulation, he brings a valuable knowledge base to GMED.

“GMED provides a culture that values expertise and I’m proud to be part of a team of committed scientists, engineers, and physicians all working to ensure patient safety while helping to bring to market innovative, life-saving medical devices. Additionally, the people here at GMED are what make this place special. There is an undeniable spirit of positivity and supportiveness that makes working here a fulfilling experience. We all work together to share knowledge and help each other.”

“The role of Product Reviewer/Evaluator at GMED North America requires a very interdisciplinary approach. One has to be knowledgeable of all the applicable standards and regulations, and of course stay on top of the latest medical device technology and engineering while closely monitoring clinical trends. But more than that, it requires a holistic awareness of the big picture, and the ability to connect pieces of information scattered among an enormous volume of important details. This is all in the pursuit of answering the question “is this device safe and effective?” The role is very challenging and rewarding, and I’m happy to know that as a result of my work, patients are getting access to medical devices that they can be sure have been through rigorous screening.”