Senior Regulatory Affairs Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Regulatory Affairs Specialist based in the United States. The Senior Regulatory Affairs Specialist will play a key role in supporting the regulatory strategy and market access of medical devices and in vitro diagnostic (IVD) products across U.S. and international markets. You will prepare and manage regulatory submissions for new and modified products, while guiding product development teams on applicable requirements. The role combines regulatory strategy, clinical study oversight, risk assessment, and direct interaction with regulatory agencies. You will collaborate cross-functionally to ensure products and supporting documentation meet applicable regulatory standards throughout development and commercialization. Your expertise will help shape regulatory pathways, address agency requests, and support successful product approvals and continued market access. This is a remote opportunity for an experienced regulatory professional who enjoys working across technical, clinical, quality, and business functions.