Regulatory Affairs Coordinator

Join to apply for the Senior Regulatory Affairs Coordinator role at MillenniumSoft Inc . Position: Senior Regulatory Affairs Coordinator Location: Irvine, CA Duration: 12 Months Total Hours/week: 40.00 Shift: 1st Shift Client: Medical Devices Company Job Category: Clinical Level of Experience: Senior Level Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT) Key Responsibilities Support US and EU regulatory submissions (exercising judgment to protect proprietary information); track timelines and document milestone achievements. Participate in assessing and collating regulatory impact and developing regulatory strategy. Collaborate and approve change requests/change notifications. Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and labeling content. Other incidental duties assigned by Leadership. Additional Skills Coursework, seminars, and/or other formal government and/or trade association training required Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel Good written and verbal communication skills and interpersonal relationship skills Good problem-solving, organizational, analytical and critical thinking skills Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices Solid knowledge and understanding of global regulatory requirements for new products or product changes. Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships Education And Experience Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry) 5-7 years of experience required #J-18808-Ljbffr