Grace Powers

Grace Powers

Founder, Powers Regulatory Consulting
Smyrna, GA (USA)

RAC holder since 2010

 
 

How did you get into a regulatory career?

I learned about regulatory affairs when I started my first R&D job—just out of graduate school—at a mid-size medical device company. I worked in R&D (mostly catheter engineering) for five years and then made the transition into regulatory affairs at a start-up. I realized that I enjoy writing and telling the story of the medical device more than I liked testing in the lab.
 

What was an especially memorable moment for you on the job?

My first 510(k) clearance in 2006 was a really big accomplishment! Also running my first full Pre-Submission meeting on campus at the FDA was very memorable as well.
 

What motivated you to pursue the RAC certification?

I wanted to show my commitment to my career and the medical device industry by gaining the RAC certification. Also, I felt that, as a manager, I needed to have the RAC certification if I wanted to motivate members of my team to get certified. Under the previous system of geographic tests, I achieved the USA certification first, then global certification and finally the EU certification.I’m a staunch believer in the value of the RAC—so much so that I volunteer to support the program however I can.
 

How has your certification aided you in performing your job?

As an independent consultant, I have found that clients really want to ensure that you have a good foundation in all areas of regulatory. The certification helps demonstrate this.
 

How has earning the RAC help you tackle a specific business issue?

The knowledge and skills gained while working toward certification really helped me during due diligence projects. When reviewing another company's documentation, it is so helpful to have background in areas that aren't just the focus of your own company. I was more familiar with some of the areas that I needed to review due to exam preparation.
 

What steps would you recommend to someone thinking about achieving certification?

Make sure that you have some real-world experience before you pursue the certification. Also make sure you study a lot. You can't just wing it on this test!


 
 
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