Kristen Ortiz on life as a regulatory affairs manager, her trip to RAPS Convergence and more

RAPSRAPS' Latest | 14 March 2023 |  By 

Kristen Ortiz is a regulatory affairs manager at BD, a large medtech company. She joined RAPS at RAPS Convergence 2022 for a chat about her job, her experience connecting with other regulatory affairs professionals, her decision to get her Regulatory Affairs Certification and more. 

"I’m evaluating changes to products that come up for various reasons, suppliers, manufacturing, improvements, anything like that, and then developing the next generation and new products as well, primarily for US and EU markets right now,” she says. “I'd say my favorite part of the job is working with the cross-functional teams to figure out a strategy. 'Here are the regulations, here's what we want to do, what pathway can get us there?'” 

Kristen, a RAPS member since 2012, was one of 1,700 attendees who joined us for RAPS Convergence 2022 in Phoenix, our first in-person conference in the US since 2019. She told us why she found the experience valuable. 

“I think one of my takeaways is that people are having similar struggles and things that we're needing to work through with newer regulations and things coming out,” she said. “So just understanding that we're not alone and asking questions and things like that. Not that there's solutions to everything, but that it's kind of known as something that everyone needs to work through.”


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