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USA - California – Irvine; USA IRV-1442 Alton/MIC
Source: Edwards Lifesciences careers · View original posting
From Edwards Lifesciences's posting. “We” and “our” refer to the employer.
Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AI&T team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.
This role will play a pivotal role in leading AI-enabled transformation across Edwards' clinical development and regulatory operations, with initial emphasis on trial acceleration, clinical safety workflows, and submission automation. It does not replace the accountable Clinical Affairs, Safety, Biometrics, or Regulatory functions. It shapes the transformation agenda, co-owns measurable cycle-time and quality outcomes with those leaders, and mobilizes product, data, engineering, and change capabilities to deliver them.
Bachelor's Degree in related discipline, with 12 years of experience in clinical development operations, data management, biometrics, or regulatory operations, or equivalent leadership at a clinical technology vendor or CRO -OR- Master’s, PhD, or other advanced degree with 10 years of experience in clinical development operations, data management, biometrics, or regulatory operations, or equivalent leadership at a clinical technology vendor or CRO
A record of redesigning clinical or regulatory workflows and achieving measurable adoption, cycle-time, quality, or productivity improvements
Direct, personal experience closing a database lock and supporting at least one FDA regulatory submission
Experience with AI-driven pharmacovigilance case processing and signal detection, gained at a biopharma company, CRO, or safety-technology vendor: this discipline is materially more mature in biopharma than in medtech, and that experience transfers directly
For California (CA), the base pay range for this position is $202,000 to $287,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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