With a bachelor’s degree in molecular biology, Anna Freed was working in a primarily quality assurance role with a small medical device company two years ago. Today, she manages a team of QA consultants for a large, international client. What happened in between? She took the Master of Science in Regulatory Affairs online program through San Diego State University.
In partnership with the College of Extended Studies, SDSU’s College of Sciences also offers an Advanced Certificate in Regulatory Affairs (transferable to an MS degree), and — with the USD School of Law — a joint Advanced Certificate in Intellectual Property and Regulatory Affairs.
Freed answered a few questions about her journey through the Master’s program.
What prompted you to take SDSU’s Master of Science in Regulatory Affairs program?
The company I was working for at the time was very small and the QA department also performed regulatory affairs functions. QA and RA are closely related, so you need a good understanding of the regulations and requirements in order to be successful in a QA role. I was still relatively new to QA/RA; I had only two years of experience in the field. My manager had received her M.S. from SDSU’s RA program. She knew I was looking to grow in my career and suggested the program as a way to help me reach my career goals.
What had you hoped to gain and how did the program meet your expectations?
I was really hoping to gain an understanding of the regulations behind the job that I had been performing. The program definitely met my expectations. I learned about regulations behind a variety of topics, but more importantly, I learned how to interpret the regulations and apply them to different companies and situations.
What do you think are the program’s key strengths?
The flexibility and industry focus of the program are definitely its key strengths. The instructors are all industry professionals with a lot of experience to share, and they provide a framework to understanding course topics from a real-world perspective. The program also includes classes that cover both pharmaceutical and medical device regulations, and there’s a variety of electives and special topics to choose from that fit individual needs.
How long did the program take?
It took me two years to complete the classes, and five months for the final capstone (thesis) project.
What was your thesis project?
My thesis project was to develop a program for a company looking to transition from an unregulated, research use only [RUO] company, to a company that manufactures diagnostic Class III devices that are regulated by the FDA. The program I developed is meant to allow customization to any company size and structure and to change the culture of the company with minimal disruption to manufacturing.
What did you think of the caliber of instructors and their accessibility?
All of the instructors were great. They were extremely knowledgeable about their subjects and because they are industry professionals, they included real-life case studies and examples in many classes. The instructors were accessible and answered any questions that came up while I was working on assignments for each class.
Can you speak to the networking aspects of the program?
Every class had students share their LinkedIn profiles and I connected with a few individuals who were working or had worked in the same medical device companies as I. I found it useful to connect with the other students and discuss our career paths and challenges.
How has your Master of Science degree impacted your career?
I saw an immediate difference in my career when I started the program. Starting the program showed my commitment to personal growth to the management team at my previous company, which led to me being designated the lead on several large and very visible projects, which eventually led to a promotion. I got offered a consulting position about a year ago, and was promoted to the management team of the consulting company in the last few months because of my performance and relationships with the client. I now manage a team of QA consultants for a large, international client. I would not have had the necessary knowledge to perform my role if I had not completed the MS program.
For more information on the Master of Science in Regulatory Affairs and other programs offered through SDSU’s College of Sciences, please visit regsci.sdsu.edu or call (619) 594-6030.