Main Responsibilities of a Regulatory Affairs Analyst at Large Medical Device Company
Initially, Ryan's main responsibility at Applied Medical involved "complaint intake from the field," requiring product knowledge and skillful communication to gather crucial details. As Ryan's seniority increased, their role evolved into a leadership position, tackling strategic initiatives like recall discussions and establishing international complaint-handling teams, showcasing career progression from individual contributor to organizational leader.
Problem-Solving, Communication, Teamwork, Leadership, Regulatory Affairs
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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. Working on complaint intake from various sources, requiring product knowledge and communication skills to gather necessary information and determine the severity of issues.
2. Collaborating with engineering and regulatory teams to categorize issues, escalating serious problems to management, and conducting further investigations as needed.
3. Developing leadership skills and taking on a bigger picture role, leading teams, and strategizing on issues like recalls and team expansion into new regions.
Transcript
Ryan, what are your main responsibilities at Applied Medical?
When I first joined Applied Medical, my main responsibility was complaint intake. This involved receiving reports from the field, whether from nurses, doctors, or salespeople, who would call or email my team about an issue.
They would let us know if a device was returning or if there was a problem. At that point, I had to be familiar with the products our company sells and understand what the engineering team might need for follow-up questions. I also had to know how to converse with the person reporting the issue.
This included asking questions like: Was there any patient injury? What part of the device broke? How did the issue affect the completion of the surgery? And were there any other issues related to the device?
After documenting this information in the system, I would pass it along to members of the regulatory and engineering teams. If the issue was simple, my responsibility ended there.
However, for more complex issues, the regulatory and engineering teams would come to me. We'd discuss what information was needed to properly categorize the issue. We'd also determine if it was something we needed to inform management about, especially if it was serious and required a significant response.
Based on these conversations, I would often need to go back to the initial reporter to gather more information. As I became more senior and eventually led the US team for this segment, my responsibilities expanded into more of a leadership role.
I no longer handled most of the complaint intake. Instead, my focus shifted to bigger picture issues. This included discussions about recalls and how we would launch a customer satisfaction team, for example, in Singapore.
We also discussed how to prepare the Mexico team to handle complaints independently, rather than escalating them to us. Because of my experience, I was relied upon more for these strategic discussions and organizational issues. My role also involved translating what my team did to other teams within the organization.
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