Biggest Challenges Faced By a Regulatory Affairs Analyst at a Large Medical Device Company
A Regulatory Affairs Analyst faces the significant challenge of obtaining necessary information from various sources, with unresponsive personnel sometimes hindering timely responses to serious patient issues; "it feels like it's going out into the void," leading to meticulous documentation of attempts to secure crucial data for regulatory compliance. This role also presents the challenge of a potentially pessimistic mindset from constant exposure to failures, necessitating a focus on the context of these events as a small fraction of overall successful outcomes.
Communication, Problem-Solving, Resilience, Overcoming Challenges, Industry Realities
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Ryan Perera
Regulatory Affairs Analyst
Large Medical Device Company
UCLA 2015
Boston University: Master’s in Medical Sciences (2018) UCLA: MBA (2024)
Biology & Related Sciences
Healthcare, Medical & Wellness
Operations and Project Management
Took Out Loans
Video Highlights
1. Difficulty in information gathering: Regulatory Affairs Analysts often struggle to obtain necessary information from various sources like doctors, nurses, or sales personnel, which is crucial for regulatory compliance and reporting to agencies like the FDA. Persistent follow-up and documentation of attempts are essential.
2. Maintaining a positive outlook: The job involves dealing with failures and adverse events, potentially leading to a negative mindset. It's important to maintain perspective, focusing on the rarity of failures within the larger context of successful devices, and actively seeking positive interactions with other teams.
3. Importance of communication and documentation: Effective communication is critical, not only for gathering information but also for documenting attempts and sharing updates with the team. Thorough documentation protects the company in case of FDA inquiries, demonstrating proactive efforts to gather information.
Transcript
What are some of the biggest challenges in being a Regulatory Affairs analyst?
The two major challenges are trying to get information from people who may not be helpful. You're not at the scene when the complete happens, so you have to rely on nurses, doctors, or the sales person to be helpful and answer your questions.
Sometimes, they just don't respond. It can be something serious, like the status of a patient. This is information the FDA will need to know for regulatory responsibility. When you're just sending emails and not getting responses, it feels like it's going out into the void.
This can be very challenging, so you have to find new ways to get that information. Sometimes, you have to reach out to the nurse directly if the sales person isn't responding. Other times, you have to go through the sales person who covers your territory to get your questions answered.
In the worst-case scenario, if it's impossible to get information, you need to communicate that to your team. Make sure you document all your attempts to get this information. So, if the FDA comes asking, you can show that you made multiple attempts, and they went nowhere.
On the flip side, on a more internal level, my job involves seeing most of the failures that happen in the company. This can sometimes create a pessimistic mindset. If you're only seeing the bad things, you can start to doubt how much good you're doing.
It's important, especially in regulatory roles, to keep in mind the context of what's happening. Failures, if you're working at a good company, should only be a small fraction of the devices being sent out. Any events involving patients should be incredibly rare.
So, keeping that context in mind is key. Talking to people outside your team who have more positive information can help. Even if you see something concerning or have a bad complaint, remember that it could be a bit tough.
Overall, just keep in mind the context and know that seeing failures doesn't mean a lot of good isn't being done at the same time.
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