Edwards Lifesciences Specialist, Regulatory Affairs - Critical Care in Irvine, California
Completes and maintains regulatory approvals and clearances of assigned products.
Key Responsibilities: • 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 conflicts between those requirements and development issues, and/or reporting to management • Prepare and oversee documentation packages for submission to global regulatory agencies. 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) • Provide guidance on regulatory requirements necessary for contingency planning • Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes 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 • Prepare documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions • Other incidental duties assigned by Leadership.
Education and Experience: Bachelor's Degree in related field, 3 years years experience related experience Required or Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry), 3 years years experience preparing domestic and international product submissions Preferred
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. • Solid knowledge of new product development systems • 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 • 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 13,000 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.