**Regulatory Affairs Specilaist II** Clinical Regulatory Affairs Specialist II, TX, US Pay Rate Low: 35.00 | Pay Rate High: 56.41 + Added - 28/01/2025 Apply for Job **Exciting Regulatory Affairs Specialist II development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.** **Regulatory Affairs Specialist II** **Location: Remote -** Preference given to DFW locals **Duration:** 12 months **Pay Rate: 35.00-56.00 DOE** + **Update technical documentation files to align with EU MDR medical device requirements** + **Submit Regulatory Impact Assessments to countries using Veeva system and ensure completeness of assessment from countries** + **Coordinate submission package** + **Manage country timelines to support approval of lifecycle management changes for medical devices** + **Collect data from Technical Documentation File in preparation for Eudamed go-live** + Verify registration data in Veeva database for US and Canada medical devices + ED MDR + Medical Device Regulatory experience + Bachelor's Degree This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! \#INDBH \#LI-DNP: We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.