Meet the Team at Reed Tech
Maura Gouak, Sales Development Representative, Medical Devices
Q: What aspects of your job are most motivating?
A: Medical device regulatory requirements for the U.S. FDA and soon, other countries, is overwhelming. Sometimes, it is challenging for companies to try and relate the information they have already gathered for the FDA to what data is reusable for another region’s requirements. It is an exciting time as we go into the EU UDI requirements of 2020, knowing that SingleSource™ for Medical Devices helps to pull all of those attributes together.
I had an injury to my hand earlier in 2019 that required surgery with a pin implanted to strengthen my pinkie finger. Going through that process as a patient made me realize all the aspects to consider when it comes to medical device safety. A complex chain of events occur in a device product lifecycle. The awareness of what materials devices are made of, how they are designed and manufactured and how the FDA works has been illuminating.
The types of solutions offered by Reed Tech can play a critical role in the lifecycle of a medical device coming to market.
Q: What kinds of challenging problems does your job allow you to solve for customers?
A: With all jobs, there are challenges. When I discover a company that is facing timing issues, unaware of regulations, or just starting the process of looking for guidance, it is a great relief to know that if I don’t have the answer, I have team members who do. Reed Tech has subject matter experts who are continually monitoring regulatory authorities for the latest information and interpretations.
Q: What is one of your favorite quotes?
A:“Don’t give up – Don’t ever give up!”
This is a quote that my coach from soccer said when I was younger. I apply this to all aspects of my life – at home, work, school. It took me longer than expected but I got an associate’s degree, and I am currently pursuing a bachelor’s degree from Albright College. My son is a big chunk of that motivation!
Sales Development Representative, Reed Tech Life Sciences
Maura is continually learning about real-life scenarios and data management concerns for regulatory affairs, IT and supply chain professionals. She connects information seekers with subject matter expertise.
In her spare time, she is working on her Bachelor’s Degree with a focus on Accounting.
Learn more about Reed Tech solutions and services for Life Sciences