A Day In The Life Of A Regulatory Affairs Analyst At A Medical Device Company
A Regulatory Affairs Analyst's day-to-day involves prioritizing and addressing incoming complaints, often from global sources like "Japan hospitals," and meticulously following up on outstanding requests from sales teams to ensure thorough investigations for regulatory compliance. This requires flexibility to adapt to fluctuating complaint volumes, sometimes requiring teamwork to manage high-pressure situations.
Communication, Problem-Solving, Teamwork, Adaptability, Global Perspective
Advizer Information
Name
Job Title
Company
Undergrad
Grad Programs
Majors
Industries
Job Functions
Traits
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. A Regulatory Affairs Analyst's day involves managing complaints from various global sources, prioritizing and escalating complex issues to relevant teams.
2. A significant portion of the job focuses on following up on outstanding requests and ensuring timely responses from other departments, like sales and engineering, to gather information for regulatory compliance.
3. The role demands flexibility and adaptability, as the volume of complaints and urgent issues can vary greatly from day to day, requiring teamwork and effective communication skills.
Transcript
What does a day in the life of a Regulatory Affairs analyst look like?
From an entry-level perspective, your daily life usually begins with addressing complaints in the system. Since you work eight hours a day, and if it's a global company, you might receive complaints from all over the world or from different time zones.
From my experience, we often had complaints from Japan. This was because Japanese hospitals were a significant customer base for us. So, we would typically have several complaints in an inbox. The team's priority is usually clearing those out first.
This involves communicating more complex issues to the relevant teams, such as engineering, regulatory, or management, as needed. After that, you take a moment to review if there's anything else requiring follow-up.
For instance, let's say there's a complaint where an engineer needs specific information about a device failure. If you emailed the salesperson about it five days ago and haven't received a response, you would go through your outstanding requests. You'd follow up to ensure the sales team hasn't missed anything or that there's some progress being made.
This follow-up is important from a regulatory standpoint. We can't force a hospital to provide all the information we need. However, from a regulatory perspective, the FDA wants to see that we are making an effort and attempting to get the necessary details. So, a lot of the work involves handling initial complaints and ensuring follow-ups are in order.
This can change. Sometimes, a salesperson might call you, saying they were at a hospital for an appendix surgery, and an issue occurred. You need to be able to stop what you're doing immediately, document that complaint, and move it forward. This allows the rest of the team to take the necessary actions.
For an entry-level position, a lot of it is about maintaining a certain cadence and taking care of your responsibilities. However, you also need the flexibility to adapt when unexpected complaints arise.
Sometimes, you get lucky, and there are days with very few complaints. Other times, it can feel like the sky is falling, and everyone wants to reach out to you. That's a completely different situation. In those moments, you have to rely on your teammates for help.
Ultimately, it's about being flexible and adaptable to whatever the complaint volume may be on any given day.
Advizer Personal Links
No