Shikha Malik
Senior Regulatory Affairs Specialist at Medtronic
Frisco, Texas, USA
RAC holder since 2020
Why did you decide to take a RAC exam?
I got to know about the RAC from my colleagues, and when I did a little bit more digging I found out that it is the most widely recognized examination in the regulatory sector and that it could open more doors from a career perspective. So that is one of my main reasons for pursuing my RAC. I took my RAC-Devices certification in 2020 and it basically provided an overall understanding of the lifecycle of a medical device. Not just from the design perspective, but also from the launching-of-a-product perspective. Because launching a device in a market requires pre-clinical stuff, clinical stuff and postmarket information as well. The RAC involves most of the understanding of how we’re strategizing and presenting information to the regulators. The RAC not only enhances knowledge, but also provides you better aspects from the strategy perspective. Those are my main two reasons for taking my RAC examination.
How did you study for your RAC exam?
I purchased the book Fundamentals of Medical Device Regulations from RAPS and practice tests. The book itself, I’d say, is like an encyclopedia of regulatory affairs. It provides a huge amount of knowledge and every time I re-read a chapter, I feel like I’m learning something new. Apart from that, I also took multiple practice tests. This helped me understand how questions are framed on the examination, because those questions, those are not straightforward questions. They require a deep level of understanding. I also collaborated with a bunch of other folks who were also preparing for the exam on RAPS’ RegEx forum. We used to meet once a week to share our knowledge and learning.
How has your RAC helped you in the time since you earned it?
Holding my RAC credential, I feel like I have not only enhanced my knowledge but I am also now more in touch with RAPS. I am a member of RAPS’ community and I got to know about the various opportunities RAPS provides: the different kinds of events they are holding, not only offline but also virtually. This helps in turn to explore the new rules and regulations coming up in the market. And apart from that, RAPS also provides volunteering opportunities. Holding my RAC credential definitely helps me increase my chances of applying for these opportunities and getting approved for them. I’ve also worked with RAPS on authoring two chapters in upcoming books, and both came after holding my RAC credential. I think it definitely broadened my skillset. I’m also partnering with RAPS on writing questions for their regulatory compliance examination, so those are some aspects of how holding up your certification can open a few doors for you.
What advice would you give someone interested in getting their RAC?
I would say start as early as possible, first of all. It’s not at all an easy examination. It requires a lot of effort and dedication to prepare for the examination. So first of all, once you decide, or once you have enough experience, just start looking at the RAPS website, mainly for the eligibility criteria and other information required to take this examination. Once you get that and feel you are eligible for it, start preparing for the examination as soon as possible. I’d say try to give at least six months’ time for studying. Start making notes, start making flash cards. Because there are a few dates, say for example for annual adverse reporting, it’s like, you can’t memorize everything. If you do it by writing up a few things and making flash cards, it will definitely help you to prepare better for the examination.
And also, start doing practice tests that RAPS offers. That’s one of the key aspects. Start meeting with a bunch of other people who are also studying for their examination. That way you can all collaborate and interchange your knowledge and experience. These are my few intakes from my preparation that I would like to give to other people.