Senior Regulatory Specialist Our client, a medical device start-up, is currently seeking an experienced regulatory professional to join their team. The Senior Regulatory Affairs Specialist will work closely with a cross-functional team to obtain the necessary regulatory approvals/clearances for the launch of an innovative new therapy. 1. Support and advise the VP Quality and Regulatory Affairs by executing regulatory activities and developing strategies to support business needs. 2. Develop submissions to ensure timely product clearance/approval and lead preparation, review, and submission of high-quality responses to agency queries. 3. Collaborate with development teams to create data using best scientific principles, ensuring submission goals are met.