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Specialist, Regulatory Affairs, Surgical Structural Heart

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: November 19, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Specialist, Regulatory Affairs - Surgical Structural Heart USA - California - Irvine Edwards has an exciting opportunity with our Surgical Structural Heart group, focused on transforming patients' lives by advancing surgical structural heart innovations. The Specialist, Regulatory Affairs will represent regulatory affairs on product development and EU MDR teams related to Surgical Heart Valve products. Key Responsibilities: Completes and maintains regulatory approvals/clearances of assigned products. Interacts with FDA and other regulatory bodies for submissions under--management guidance. Supports RA management and team leaders on complex projects and submissions. Represent the regulatory function on new product development, material and manufacturing changes, and EU--MDR teams. Review and approve protocols, reports, engineering drawings, procedures, and other--documentation to ensure regulatory--compliance, consistency, and accuracy. Responsible for Post-Market regulatory compliance activities, including annual reports. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory--plans. 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. Other incidental duties Education and Experience: Bachelor's degree (science or engineering discipline preferred) plus minimum of 3 years of related experience required. Or Masters Degree plus minimum of 1 year related experience required Experience preparing Class II and/or Class III domestic and international product submissions is required.
Additional Skills: Excellent problem-solving, organizational, analytical and critical thinking skills Excellent written and verbal communication skills including negotiating and relationship management skills 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 key contact representing the organization on projects Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Posted 2 Days Ago Full time Req-9819 About Us Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.-- For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Keywords: Edwards Lifesciences Gruppe, Irvine , Specialist, Regulatory Affairs, Surgical Structural Heart, Healthcare , Irvine, California

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