Edwards Lifesciences Senior Specialist, Regulatory Affairs - Critical Care in Irvine, California
This is an outstanding opportunity to be a part of a forward-thinking regulatory affairs organization. The Senior Specialist, Regulatory Affairs will focus on supporting projects for our critical care products. We are looking for a diligent Sr. RA professional who works well across functional teams, takes initiative, and enjoys working in a fast-paced team environment.
Participate as an active member of the EU MDR transition team.
Represent regulatory affairs on product development, commercialization, and sustaining teams related to Critical Care Products.
Interacts with FDA and other regulatory bodies under management guidance for submissions and projects.
Will monitor proposed and current US and EU regulations and guidance, and will advise the impact of such regulations and guidance on the company within the scope of assigned
May provide regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.
Able to collaborate and take direction from team leaders, while working with RA management on resolution of RA issues and strategy.
Qualifications/Required Skills/Experience and Education:
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 required with a Master’s degree.
Experience with Class II devices is required. Experience with hemodynamic monitoring devices is preferred.
Experience preparing US and EU product submissions is required. Knowledge of EU MDR is preferred. Knowledge of Canada, Australia, and New Zealand submissions preferred.
Must be competent in applying the appropriate regulatory requirements for new products or product changes as it relates to labeling (and advertising) of class II and III devices. – Requires familiarity with new product development systems.
Must possess a strong working knowledge of US /EU regulations that affect Class II and/or Class III devices.
Must have strong written and verbal communication skills, and have experience working on cross functional project
Strong ability to problem solve and apply analytical thinking is required.
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.