Grace Powers

Emily Nesbitt

Associate Director, Regulatory Affairs
Ethicon, J&J
Montgomery, OH (USA)

RAC holder since 2010

 

What is a typical day like for you?

There is no such thing as a typical day for a regulatory person who is dedicated to the profession and believes in their products! To really contribute to the development of our devices, I need to dive deep into complex situations and find the heart of the question. Sometimes I spend days working with our supply chain department, helping them get needed government clearances to get our products through Customs. Lately, I spend a lot of time with our marketing department, helping them understand the new EU Medical Device Regulation (MDR) requirements that impact the launch of a new product in the European Union. At the end of the day, I tell my teams that my job is to present their work to FDA to tell the full story of a product and keep us complaint to the regulations.  
 

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

There are so many moments where I have been proud to be a regulatory professional, but the one moment that really sticks out to me is when I was the regulatory partner supporting energy devices for our company, about 8 years ago. We were working to get a new energy Harmonic® device approved for use in a South America country. The region was a very high priority—there was a lot of pressure and many long hours spent on the registration activities. Within a month of approval, the device was used by surgeons for conjoined twin babies. Blood loss was a big concern for the babies. The surgery was a success and the surgeons said they couldn't have done that procedure successfully without the device. I like to think that is the best part of our job as regulatory professionals—we get products into the hands of the doctors and patients who need them the most.
 

How has your certification aided you in performing your job?

I first became certified in 2010. I remember the first time I added the "RAC" to my signature line. I was having a particular difficult conversation about a regulatory matter, and I noticed that the entire tone of the email exchanged changed once I had added "RAC" to my signature line. It felt like the credential added a little extra confidence in my level of knowledge. People seemed to respect my advice more.
 

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

I feel very fortunate to work among some of the most ethical and brilliant people in the world. Our profession sees the best of both worlds. We get to work on teams of doctors and engineers to create new products for patients, and then we take all the knowledge to work with our health authorities towards product approval. Regulatory professionals are fortunate because we get to see all sides.



 
 
 
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