Edwards Lifesciences Senior Specialist, International Regulatory Affairs - Critical Care in Irvine, California
The Senior Specialist, International Regulatory Affairs plays a key role within the high-performing Regulatory Affairs team, supporting the completion and maintenance of regulatory approvals and clearances in the Rest of World region (globe minus US, EU, Canada & Australia).
With limited supervision, work on Regulatory Affairs team responsible for support of international registrations.
Represent team on project teams to the larger Regulatory group and other departments. Support team members through cooperation and teamwork (Japan focus).
Work with overseas Regulatory affiliates to negotiate and define requirements for regulatory submissions, including new product dossiers, partial change amendments & notifications, deficiency responses and if needed support external audit process.
Create regulatory submissions by identifying and using existing documentation where possible, or managing creation of new documentation, working directly when needed with Subject Matter Experts in outside departments (R&D, Manufacturing, Quality, etc.). Provide documentation to foreign Regulatory affiliates to support product registration.
Maintain awareness of regulatory environment in target countries, including proposed and current regulations and guidance documents; ensure the environment is appropriately reflected in regulatory strategies.
Support and strengthen the communication processes between International RA and the Business Unit RA Team
A Bachelor’s degree in a related field is required; a scientific discipline is preferred.
A minimum of five years of related experience is required with a Bachelor’s degree, OR, a minimum of three years of related experience is preferred with a Master’s degree.
Class II and Class III international regulatory affairs experience within the medical device industry is preferred.
Must possess a strong working knowledge of international regulations. Experience preparing international product submissions is preferred.
Must be competent in interpreting global regulatory requirements for new products or product changes as it relates to Class II and III devices. Requires familiarity with new product development and product change control systems.
Must have strong English written and verbal communication skills, and have experience working on cross functional project teams.
Excellent problem-solving, organizational, analytical and critical thinking skills.
Ability to manage competing priorities in a fast-paced environment
The time is now to join Critical Care. Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for continuous learning and professional advancement.
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.