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Senior Specialist, Regulatory Affairs, Critical Care
1 month ago
For over 50 years, the Critical Care product group within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology. If you're a dynamic and passionate person who is eager to contribute to innovative, industry-leading advanced technology, we invite you to explore our career opportunities. We believe those who join us will be part of an inspiring journey to improve the quality of care for millions of patients around the world. How you will make an impact: Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions. Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans. Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files). Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process. Review labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy. Other incidental duties. What you’ll need (Required): Bachelor’s Degree in a related field and 5 years of previous related experience OR Master’s Degree in a related field and 3 years of previous related experience. Coursework, seminar, and/or other formal government and/or trade association training. What else we look for (Preferred): Bachelor’s or Master’s degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry). Experience in preparing EU design dossiers or technical files and US 510(k)s. Full knowledge and understanding of EU and US regulations relevant to medical devices, Class II and/or Class III devices. Full knowledge and understanding of EU and US requirements for product changes for disposable marketed products (catheters, minimally invasive sensors, pressure monitoring devices, blood management devices). Full knowledge of change management systems. Proven expertise in Microsoft Office Suite including Word, PowerPoint, and Excel. Excellent written and verbal communication skills including negotiating and relationship management skills. Excellent problem-solving, organizational, analytical, and critical thinking skills. Strict attention to detail. #J-18808-Ljbffr
