Regulatory Affairs Specialist

Our client, a leading organization in the medical device and diagnostics industry, is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be part of the Regulatory Affairs department supporting global product registration and compliance initiatives. The ideal candidate will demonstrate meticulous attention to detail, proactive communication skills, and a strong commitment to regulatory excellence, which will align successfully in the organization. Job Title: Regulatory Affairs Specialist Location: Irvine, CA (Hybrid) Pay Range: $60 per hour Shift: 8 am - 5 pm, Monday to Friday What's the Job? Manage global regulatory submissions, registrations, renewals, and maintenance activities to support new and modified products across international markets. Ensure product claims, labeling, Instructions for Use (IFUs), and supporting documentation meet applicable global regulatory requirements. Coordinate responses to regulatory authority questions and information requests with cross-functional partners. Manage Regulatory Affairs change requests and maintain audit-ready records. Maintain technical documentation to support CE Marking and other regulatory requirements, coordinating labeling changes and updates to stakeholders. What's Needed? Bachelor's degree in Biology, Chemistry, Medical Technology, or a related scientific discipline. 5+ years of experience in domestic and international regulatory affairs or regulatory compliance, preferably within the in vitro diagnostics (IVD) industry. Extensive knowledge of global regulatory requirements, including FDA, NPMA, and IVDR. Strong understanding of product labeling requirements and international product registration processes. Proficiency in computer applications, including Quality Management systems such as SAP, and the ability to perform basic statistical analysis. What's in it for me? Opportunity to work in a dynamic and innovative environment focused on advancing healthcare solutions. Engagement in meaningful projects that impact global health and safety standards. Collaborative team culture that values diversity and professional growth. Supportive work environment with opportunities for skill development and career advancement. Upon completion of waiting period associates are eligible for: Medical and Prescription Drug Plans Supplemental Life Insurance Short Term Disability Insurance 401(k) #J-18808-Ljbffr