Edwards Lifesciences Senior Specialist, Regulatory Affairs - Transcatheter Heart Valve in Irvine, California
The Sr Specialist, Regulatory Affairs completes and maintains regulatory approvals and clearances of assigned products within the Transcatheter Heart Valve (THV) portfolio.
• Represent the regulatory function on product development and manufacturing 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. 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, 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
Education and Experience:
Bachelor's Degree in scientific discipline plus minimum 5 years relative experience required
(or Masters Degree in related discipline plus minimum 3 years relative experience)
Experienced in preparing domestic and international product submissions highly preferred
• 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
• Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Full knowledge and understanding of global regulatory requirements for new products or product changes.
• Full knowledge of new product development systems
• Good leadership skills and ability to influence change
• 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 contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• 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 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.