What A Regulatory Affairs Analyst At A Large Medical Device Company Wishes They Had Known Before Entering The Medical Device Industry
Ryan, a Regulatory Affairs Analyst, wishes they had known the extensive regulations involved, particularly the "huge legal risk" differences between countries like Europe and the US, before starting their career. The analyst advises aspiring professionals to proactively seek input from various teams and "don't be afraid to ask questions," leveraging experience from senior colleagues to navigate the complex regulatory landscape.
Regulations and Compliance, International Collaboration, Communication and Teamwork, Proactive Problem-Solving, Continuous Learning
Advizer Information
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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. The regulatory landscape for medical devices is complex and varies significantly between countries. Understanding international regulations and their implications is crucial.
2. Proactive communication and collaboration with colleagues across different departments (e.g., sales, European teams) and regions is essential to avoid legal issues and ensure compliance.
3. Don't hesitate to ask questions and seek guidance from experienced professionals. Learning from others' experience is valuable in navigating the complexities of the field and understanding unspoken rules and processes.
Transcript
Brian, what have you learned about being a Regulatory Affairs analyst that you wish someone had told you before you entered the field?
One challenge is the sheer volume of regulations. Especially working in a national company, you have many people to consult and consider when making project changes.
For instance, I worked closely with the European team, particularly when I was more senior. I had an idea: perhaps we should ask our salespeople to provide pictures when an issue occurs. I initiated the process of going through the system, and the European team responded, "Wait, hold up. This is very illegal."
There's so much privacy legislation in Europe that doing something like that presented a huge legal risk. I wish I had understood earlier just how many regulations are involved with devices and how much they can differ between countries.
It's important to be proactive in reaching out to different people in advance. You won't know everything, but you can understand the most critical things to consider when making changes or documenting for compliance.
This understanding takes time to develop. There's so much information, and some people simply know things from experience. They might recall a specific instance because they've been with the company for years and seen everything.
Especially when you're starting out, don't be afraid to ask questions or lean on more experienced colleagues. As you spend more time in this field, the regulations begin to make more sense, and things become a lot easier.
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