Coord 3, Regulatory Affairs - Onsite

Title: Senior Regulatory Affairs Coordinator – Level 3 (Contract W2, 12‑Month) Location: Irvine, CA Schedule: 40 hours/week, 1st Shift Client: Medical Devices Company Responsibilities Support US and EU regulatory submissions, exercising judgment to protect proprietary information. Participate in assessing and collating regulatory impact and developing regulatory strategy. Collaborate and approve change requests/notifications. Provide guidance and feedback to business unit regulatory teams on registration requirements for product and process changes. Perform other incidental duties as assigned by Leadership. Additional Skills Coursework, seminars, or other formal government and/or trade association training. Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel). Strong written and verbal communication and interpersonal relationship skills. Problem‑solving, organizational, analytical and critical thinking skills. Solid knowledge of global regulations for Class II and/or Class III medical devices. Solid understanding of regulatory requirements for new products or product changes. Strict attention to detail. Professional interaction with all organizational levels. Ability to manage competing priorities in a fast‑paced environment. Teamwork and inter‑departmental collaboration, including representing the organization on specific projects. Ability to build productive internal and external working relationships. Education & Experience Bachelor's Degree or equivalent in a scientific discipline (Biology, Microbiology, Chemistry, etc.). 5–7 years of relevant experience. #J-18808-Ljbffr MillenniumSoft Inc