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Ryan, Regulatory Affairs Analyst at Large Medical Device Company: Advize Career Interview
A career path initially aimed at clinical medicine unexpectedly shifted toward the dynamic world of medical device regulatory affairs.
The journey began with a post-market analyst role, handling product complaints and recalls, and evolved into a leadership position managing international teams.
A typical day involves prioritizing complaints, collaborating with diverse teams, and ensuring regulatory compliance. Success requires strong organizational skills, adaptability, clear communication, and the ability to learn quickly.
The most rewarding aspects include constant learning, interaction with diverse professionals, and the tangible positive impact on patient lives.
Challenges include obtaining information from various sources and maintaining optimism amidst exposure to product failures. A political science minor, leadership experience, and foundational science courses proved unexpectedly valuable.
The interviewee highlights the importance of understanding different communication styles, navigating extensive regulations, and the significant legal risk differences between countries.
Aspiring professionals should seek entry-level positions and proactively seek mentorship from experienced colleagues.
The interviewee's South Asian heritage influenced initial career choices, highlighting the impact of background and cultural expectations on career paths.
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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
Operations and Project Management
Took Out Loans
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Career Path Of A Regulatory Affairs Analyst At Large Medical Device Company
Ryan's career path deviated from the initial goal of becoming a doctor, shifting toward the "infrastructure" of healthcare after realizing a preference for "problem-solving" over clinical medicine. This led to a post-market regulatory affairs analyst role at Applied Medical, where they handled product complaints, recalls, and customer outreach, dealing with issues ranging from minor manufacturing defects to serious device failures requiring FDA communication.
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.
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.
Most Important Skills For A Regulatory Affairs Analyst At A Large Medical Device Company
A Regulatory Affairs Analyst's success hinges on "organization," effectively managing multiple requests and communicating information clearly across diverse teams—from engineering to sales and clinical staff. The ability to learn quickly, convey confidence while admitting knowledge gaps ("I don't really know what goes into a God bless surgery"), and bridge communication styles between these various groups are equally crucial for success in this role.
Favorite Parts of Being a Regulatory Affairs Analyst at a Medical Device Company
Ryan, a Regulatory Affairs Analyst, finds the most rewarding aspect of the job to be the constant learning and interaction with diverse individuals—"salespeople, nurses, doctors, and engineers"—each offering unique perspectives on medical procedures and complaints. This continuous influx of new information and varied perspectives prevents boredom and fosters a dynamic career trajectory, allowing Ryan to "always feel like there's something new to learn and adapt to."
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.
Favorite parts of working in the Healthcare industry as a Regulatory Affairs Analyst
Ryan, a Regulatory Affairs Analyst, finds the most rewarding aspect of the healthcare industry is the tangible positive impact on patients' lives; "every single decision...has downstream effects on a patient," leading to a fulfilling career alongside "very fascinating people...very caring people."
What Type Of Person Thrives In The Healthcare Industry According To A Regulatory Affairs Analyst At A Medical Device Company
Ryan, a Regulatory Affairs Analyst, highlights a passion for healthcare and a "willingness to learn and adapt" as crucial for success in the industry, acknowledging that "Healthcare is also...not always good outcomes," requiring optimism and mental fortitude.
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.
Entry-Level Positions For Aspiring Regulatory Affairs Analysts
Entry-level regulatory affairs roles, such as post-market regulatory analyst positions investigating returned devices, are accessible to recent graduates; a year or two of relevant lab experience, perhaps gained at companies like "Quest Diagnostics or J&J," significantly improves job prospects in this field.
Significant Career Lesson From a Regulatory Affairs Analyst at a Large Medical Device Company
A significant career lesson for Ryan, a Regulatory Affairs Analyst, is understanding that "people have different styles and personalities," requiring adaptable management and communication strategies. This understanding, exemplified by Ryan's experience adapting to a "vibrant personality" boss and managing a diverse team with contrasting work styles, proved crucial for career success.
College Experiences That Helped a Regulatory Affairs Analyst at a Large Medical Device Company Succeed
Ryan's UCLA experience prepared Ryan for a Regulatory Affairs Analyst career through foundational science courses, building "leadership style" in Habitat for Humanity, and surprisingly, a political science minor. The minor's focus on subjective arguments and dealing with uncertainty proved invaluable in Ryan's current role, where "very rarely is there a situation where I have all information I need."
How Identity Influenced A Regulatory Affairs Analyst's Career At A Medical Device Company
Ryan's South Asian heritage initially channeled career choices, stemming from "stereotypical immigrant pressure" to pursue healthcare, a field where their background provided both an advantage and, at times, a source of distraction. While initially benefiting from a large representation of similar backgrounds, the experience highlighted how standing out in certain environments can unexpectedly shift the focus away from professional contributions.
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