Jemin spent over 15 years in the medical device industry. His roles included team lead at the FDA, regulatory affairs manager at Stryker, and most recently, regulatory affairs consultant with Hogan Lovells, a global leading law firm. Throughout his consulting career he has focused on regulatory initiatives, working with companies ranging from early-stage startups to Fortune 500 companies worldwide. During his career, he has authored and reviewed numerous FDA and Notified Body submissions (e.g., Q-submissions, 510(k)s, De Novos, PMAs, IDEs, HDEs, pre-RFDs, RFDs, 513(g), design dossiers, technical files, and technical documentation). Additionally, Jemin has experience in developing regulatory strategies for new products across various therapeutic areas. Throughout his career, he has led teams of regulatory professionals, both during his time at the Agency and in the medical device industry. He is skilled in collaborating and building consensus with a variety of stakeholders, including the FDA, Notified Bodies, the medical device industry, standards organizations, advocacy groups, and key opinion leaders.