Edwards Lifesciences Veterans Jobs

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Edwards Lifesciences Associate Manager, Regulatory Affairs- Forecasted Openings in Irvine, California

Title: Associate Manager, Regulatory Affairs- Forecasted Opportunity

Description:

This position has been posted in anticipation for future openings within Regulatory Affairs. If you meet the minimum requirements, you will receive additional information about our Regulatory Teams

An Associate Manager generally represents regulatory affairs on a variety of product development as an individual contributor, guide teams to provide content for US and/or International submissions and participate in design reviews as needed. They will typically prepare document packages for submission to global regulatory agencies, IDEs, 510(k)s and CE marking design dossiers, technical files and international design dossiers and change notifications.

Responsibilities:

  • Participate as an active member of the EU MDR transition team.

  • Monitor proposed and current global regulations and guidance; advise on impact of such regulations and guidance on the company within the scope of assigned project(s).

  • Will interact directly with Regulatory Agencies under management guidance.

  • Responsible for regulatory promotional material, labeling content, product and process changes, and product documentation; analyzes and recommends appropriate changes.

  • Communicate and maintain productive constructive relationships with Edwards Lifesciences external customers as required – US FDA, distributors, third-party in-country regulatory representatives, and notified bodies.

  • Perform other duties as assigned by RA leadership.

Qualifications/Education:

  • A bachelor’s degree, with a minimum of eight years of related experience is required, OR, a minimum of six years of related experience is required with a master’s degree.

  • Experience with IDEs, PMAs and/or 510(k) medical device products is required.

  • Experience writing FDA submissions required.

  • Direct and matrix supervisory experience a plus.

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. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

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.

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