What career mixes the best of STEM education and experience with the art of communication and raises the stakes for someone who thrives on attention to detail?
Regulatory affairs.
Rapidly evolving medical device innovations, a shifting regulatory landscape and demand for faster approvals mean there are growing opportunities in the field. Managing the regulatory affairs process requires the ability — and the agility — to balance many skills, including those outside traditional engineering disciplines.
"I believe people with technical degrees and expertise should consider regulatory because their analytical approach to solving problems is so essential when dealing with the complexity of emerging regulatory challenges," Associate Director of Regulatory Affairs Gabriela Parana said. "It is also important to combine strong technical writing with being an engaging and effective storyteller."
Gabriela Parana, Associate Director of Regulatory Affairs
Reporting data and supporting evidence in a compelling yet concise fashion comprises one side of the regulatory approval equation. Another component of the job requires an ability to read and interpret regulations from agencies around the world and anticipate questions those regulators might have.
When Abbott released a new app feature that updated its neuromodulation platform, every aspect of regulatory affairs came into play. With remote programming and video chat capabilities, the app provides options for patients to have virtual clinical visits with their doctors. While this digital innovation maintains the patient's existing medical treatment, other considerations, like its additional capabilities, cybersecurity controls and required software updates, must be validated by supporting evidence before U.S. Food and Drug Administration approval.
"When developing a regulatory strategy for medical devices, we need to understand what new questions of safety and performance might be introduced and what scientific evidence is required to demonstrate safety and effectiveness," Parana said. "In partnership with our cross-functional teams, we demonstrated that the updated app did not introduce any new risks to clinical performance. We then focused on how our software, cybersecurity and usability data validated the change introduced. We spent a significant amount of time explaining our thought process and received approval with minimal questions from the FDA."
This cross-functional role requires the ability to interact with technical and non-technical teams, collaborate to define the most creative ways to glean evidence throughout the process, and communicate results to different stakeholders. Regulatory affairs specialists need to adjust their communication styles accordingly and technical expertise helps them quickly distill complex information.
"The regulatory approval process depends on the nature of change of the product," Director of Regulatory Affairs Manasi Khare said. "These agencies may not be as familiar with the change as we are. Our work involves extensive communication and negotiation to identify the best way to address potential questions in the least burdensome manner.
Manasi Khare, Director of Regulatory Affairs
"We have limited time with agency reviewers, so we prep our technical teams to understand how to best articulate the scientific evidence. This process not only addresses their concerns effectively, but it can potentially streamline our testing timelines."
This collaborative approach delivers business impact for Abbott. And it all begins by breaking down highly technical information in the simplest way.
"My writing skills have evolved so that I can convey engineering concepts in a way that somebody who reads our submission for the first time can understand it," Manasi said. "Our approach has helped us get submissions reviewed with minimal agency questions and gives us confidence in our evidence-generation strategies for future changes."
A career in regulatory affairs offers the chance to use and improve myriad skills in new and compelling ways, all while helping to bring treatments and applications to market that can improve lives. Parana, Khare and other members of this team frequently apply their problem-solving skills to complex matters, and then communicate technical information in multiple ways to different teams, which is key to the collaborative nature of the regulatory team's work.
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