Edwards Lifesciences Associate Manager, Regulatory Affairs - Transcatheter Heart Valve in Irvine, California
The Associate Manager, Regulatory Affairs is an outstanding opportunity to be a part of one of the medical device industry’s most groundbreaking technological innovations. In this role, you will be part of a high performing new product development Regulatory Affairs team that will be responsible for the regulatory process to support multiple products in the percutaneous treatment of valve disease. Edwards has a strong pipeline in this space and the regulatory pathway is critical to getting these lifesaving products to our clinicians and patients. This role could be a significant stepping stone in your career.
We are looking for individuals with at least 6 years of experience in medical device RA, preferably in Class III devices and with exposure to PMA products. We will also consider candidates with Class II 510(k) experience.
For more information about Transcatheter heart valves click on the following link:
Represent the regulatory function on Transcatheter Heart Valve product development teams as a subject matter expert (SME) to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also recommends multiple solutions for selection by management. Prepare formal Regulatory Plans. Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
Prepare, provide direction and oversee documentation packages for submission to global regulatory agencies. Prepare GUIDID submission data. Track timelines and documents milestone achievements for inclusion in regulatory submissions. 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 strategic and contingency planning, including developing regulatory strategic plans and leading teams to implement solutions.
Review promotional material, labeling content, product and process changes, and product documentation to ensure regulatory requirements compliance, consistency, and accuracy.
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
Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on multiple projects, propose suggestions and lead the implementation on utilizing regulatory updates to expedite approval process.
Other incidental duties as assigned by Leadership
Education and Experience:
A Bachelor’s degree in a related field is required; a scientific discipline is preferred.
A minimum of eight years of related experience is required with a Bachelor’s degree, OR, a minimum of six years of related experience is required with a Master’s degree.
Experience in preparing domestic and international product submissions
Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
Excellent problem-solving, organizational, analytical and critical thinking skills
Extensive knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Extensive knowledge and understanding of global regulatory requirements for new products or product changes.
Extensive knowledge of new product development systems
Strong 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 serving as consultant to management
Ability to interact with regulatory agencies and international regulatory partners
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.