Grace Powers

Kristen Meany

Regulatory Affairs Consultant, RQM+
Northern New Jersey

RAC holder since 2008

 

How did you get into a regulatory career?

After graduating from college, I was fortunate enough to move immediately into a quality control microbiology role for an aseptically processed pharmaceutical company. The company was in the middle of FDA and EMA approvals, so I was able to participate in the drafting of various microbiological submission sections, as well as the QMS inspections. I had no idea what regulatory affairs was—there were no degree programs at the time—so I started researching certifications in quality and regulatory at the local college. After obtaining those certifications and moving to a new quality control role, I was given a chance to move into a true regulatory role at a Class II and III medical device company. My early observations and interactions with other regulatory affairs professionals really stimulated my desire to move into the field.
 

What is a typical day like for you?

There is no typical day in regulatory! While I do feel like some days are similar, every day is a new adventure. Some may think consultants have a more fluid day compared to folks in industry, but we are working on the same clock as our clients and consider ourselves an extension of their teams. My day could start with a client in the UK and end with a client on the US west coast. My day-to-day activities could be compiling a 510(k) for a medical device, working on a regulatory strategy for a software change, assessing compliance to IVDR for a IVD assay, compiling applicable regulatory intelligence, or reviewing product labeling and marketing claims. Many different products, different companies with diverse quality management systems, various levels of data—never a dull moment!
 

How has your experience earning the RAC enhanced your career?

I earned my first RAC for the US in 2008, followed by the EU in 2011. The RAC exams I took were based upon geography, allowing me to learn more about products with which I was less familiar. While most of my regulatory experience was in medical devices at the time, I had to learn more about pharmaceutical, biologics, food products, and cosmetics. Being exposed to regulations and compliance requirements for these other products has made me a well-rounded professional. I feel comfortable stepping into any type of product and utilizing the skill set developed during my RAC study to apply best practices.
 

What advice would you give to someone looking to start a career in regulatory?

Take advantage of every opportunity open to you. Most of my learning has been hands-on and not found in a textbook or through an online search. Even when I had a good plan of action for a situation, I consistently strategized with colleagues to ensure we had an optimal solution for our business, while still ensuring regulatory compliance.
 
I also encourage people to expand their business acumen by learning more about their companies and building relationships with your cross-functional colleagues. Partnership and collaboration are crucial for regulatory success. Without those relationships, you will not be a trusted partner to your business. So, get out and meet people! Understand the marketing team and their campaigns, what R&D is looking to develop, how manufacturing seeks to optimize their processes. We are all better together, and together, we will launch new and innovative products to the market.
 
 




 
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