In Regulatory Affairs, our team earns global regulatory approvals, permitting compliant access for patients to technology. My team and I have the opportunity to work with a number of cross functional partners in Regulatory Affairs, including Research and Development, Design Assurance, Quality, Clinical Affairs, Manufacturing, Process Development, Marketing, Finance, etc... to provide all the required information to support an approval decision. Each of these functions brings deep subject matter expertise to our work, and the Regulatory team collaborates with all to help build the right set of evidence to support that our offerings are safe and effective as we submit our applications to The Food and Drug Administration (FDA). We then work with 77 different countries (and their versions of FDA) to meet their specific needs and address their questions to support their review of our devices before they are approved and made available to the public.
In this role, I am constantly assessing tradeoffs, tradeoffs for various testing methodologies, proven and established versus new and offering potential advantages, evolving global regulations and standards, new materials and biocompatibility, toxicology questions, software questions, manufacturing process validations, cybersecurity concerns, clinical data collection and various study structures, inspections and audits from countries all over the world, labeling for physicians and patients, training of physicians and allied personnel, etc... The role requires a lot of listening, learning from experts, asking questions to help understand the options we have, making decisions based on what is best for patient care, and simultaneously workable for the business. I seek first to understand what our experts have learned, then dive in to define options that best utilize our resources to produce the best solutions.