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Specialist, Regulatory Affairs Operations, TMTT

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: November 22, 2021

Job Description:

Specialist, Regulatory Affairs Operations, TMTT This is an exciting opportunity to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease to transform treatment and significantly improve patients' lives. This position is located in Irvine, CA. For exceptional candidates we may consider hybrid options (in-office 2 - 3 days/week) Essential Job Functions Responsible for the compilation and publication of submission documents. Managing the coordination of submissions deliverables, schedule and tracking of appendices and documents. Participate in and responsible for quality check of submissions, including data consistency, formatting and overall quality of submissions. Responsible for filing of RA submissions and agency correspondence. Support and develop procedures, checklists, templates supporting submission quality and best practices. Point of contact and support for RA team for regulatory systems and databases. Oversee RA team training compliance. Involvement and representation on internal and external standards committees. Management and reporting out of Tier 2 assessments impacting TMTT Partner with business unit RA on ad/promo and scientific publication reviews Qualifications Bachelor's degree with 3+ years medical device or pharmaceutical industry work experience OR Master's degree with 1+ years medical device experience 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 Strong project management, problem solving and organizational skills 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 establish processes and procedures as needed Preferred experience with document management systems and software applications E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.-- 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.

Keywords: Edwards Lifesciences Gruppe, Irvine , Specialist, Regulatory Affairs Operations, TMTT, Other , Irvine, California

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