Regulatory Affairs Specialist

Regulatory Affairs Specialist, Irvine, CA (On-site/Hybrid) We're partnered with a growing medical device company in the cardiovascular space seeking a Regulatory Affairs Specialist to support ongoing product development and global market access efforts. This is a great opportunity to join a collaborative, fast-paced environment where you'll have direct impact on regulatory strategy and submissions. Responsibilities: Support regulatory strategy for Class II/III cardiovascular devices across U.S. and international markets Prepare and submit FDA 510(k), PMA supplements, and international registrations Collaborate cross-functionally with R&D, Quality, and Clinical teams on new product development and lifecycle management Ensure compliance with FDA regulations, ISO 13485, and global regulatory standards Assist in regulatory documentation, labeling review, and agency interactions Qualifications: Bachelor's degree in a scientific or engineering field 2-5 years of regulatory affairs experience within medical devices Experience with cardiovascular or implantable devices preferred Hands-on experience with FDA submissions (510(k), PMA) Strong knowledge of U.S. and global regulatory frameworks #J-18808-Ljbffr