Regulatory Affairs Lead, Transcatheter Valve Therapies

Edwards Lifesciences Gruppe; Irvine (CA); Vor Ort; USD 92.000 - 130.000; Vollzeit

Zusammenfassung

Edwards Lifesciences Gruppe in Irvine, CA is seeking a Regulatory Affairs professional to lead complex domestic and international submissions. You will collaborate with manufacturing and R&D teams to ensure regulatory compliance and timely approvals, while guiding registration strategies across multiple regions.

A strong focus on documentation and cross-functional alignment is essential. The role requires a Bachelor’s degree and at least five years in regulatory affairs for medical devices, with

Qualifikationen

• Bachelor's Degree & a minimum of 5 years related experience
• Experience in preparing domestic & international product submissions
• Solid knowledge and understanding of global regulations relevant to medical devices

Aufgaben

• Create complex regulatory submissions for finalization and submission by OUS EW affiliates; track timelines and milestones, develop regulatory strategy
• Represent the OUS regulatory function on manufacturing and product development teams, providing input on regulatory requirements and proposing alternatives
• Provide guidance on regulatory strategies and contingency planning related to OUS requirements, including impact of global regulations and expediting approvals
• Provide guidance and feedback to business unit regulatory teams on registration requirements for new and renewal submissions, product and process changes, and labeling content

Kenntnisse

Regulatory submissions

Global regulatory knowledge

Attention to detail

Ausbildung

Bachelor's degree

Jobbeschreibung

Edwards Lifesciences Gruppe in Irvine, CA is seeking a Regulatory Affairs professional to lead complex domestic and international submissions. You will collaborate with manufacturing and R&D teams to ensure regulatory compliance and timely approvals, while guiding registration strategies across multiple regions.

A strong focus on documentation and cross-functional alignment is essential. The role requires a Bachelor’s degree and at least five years in regulatory affairs for medical devices, with