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USA - California – Irvine; USA IRV-17011 Redhill/DBC1-5
Source: Edwards Lifesciences careers · View original posting
From Edwards Lifesciences's posting. “We” and “our” refer to the employer.
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
Create complex regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, develop regulatory strategy, prioritize strategies/submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada])
Represent the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management
Provide guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals
Provide guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content? and guidance on process improvement projects, based on prior experience and responses from affiliates
For California, the base pay range for this position is $92,000 to $130,000 (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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