Global Regulatory Affairs Specialist, TMTT

Edwards Lifesciences Gruppe; United States; On-site; USD 92,000 - 130,000; Full time

Job summary

Edwards Lifesciences is seeking a Regulatory Affairs professional to guide complex domestic and international submissions for our Transcatheter Mitral and Tricuspid Therapies (TMTT) business. You will coordinate with OUS affiliates, ensure milestones, and advise on regulatory strategies within manufacturing and development teams.

Ideal candidates have a Bachelor’s degree with 5+ years in regulatory affairs, plus formal training.

Qualifications

• Bachelor's degree and 5+ years related experience, or equivalent.
• Experience in preparing domestic & international product submissions.
• Coursework or formal government/regulatory association training.

Responsibilities

• Create complex regulatory submissions for finalization and submission by OUS EW affiliates.
• Track timelines and document milestone achievements, develop regulatory strategy and align with global requirements.
• Represent the OUS regulatory function on manufacturing and product development teams to address regulatory requirements and propose alternatives.

Skills

Regulatory affairs

Education

Bachelor's degree

Scientific discipline

Job description

Edwards Lifesciences is seeking a Regulatory Affairs professional to guide complex domestic and international submissions for our Transcatheter Mitral and Tricuspid Therapies (TMTT) business. You will coordinate with OUS affiliates, ensure milestones, and advise on regulatory strategies within manufacturing and development teams.

Ideal candidates have a Bachelor’s degree with 5+ years in regulatory affairs, plus formal training.