
Director, Regulatory Affairs
Edwards Lifesciences seeks an experienced and highly motivated Director of Regulatory Affairs to join their dynamic team. In this role, you will be responsible for leading the development and implementation of regulatory strategies for the company's products to ensure compliance with applicable regulatory requirements. This position requires a thorough understanding of global regulatory regulations and a demonstrated ability to develop and execute successful regulatory strategies. If you have the commitment, expertise, and passion to join a leading global medical device company, we invite you to apply! Qualifications:• Bachelor's degree in a science-related field or equivalent experience • 5+ years of regulatory affairs experience in the medical device industry• Proven experience in developing regulatory strategies and managing regulatory submissions• A strong understanding of global regulatory regulations• Excellent communication and organizational skills • Ability to work independently and as part of a team • Ability to manage multiple projects and prioritize tasks • Experience with new product development and/or engineering change process is a plus
Ability To Work In A Fast-Paced Environment
Excellent Written And Oral Communication Skills
Strong Project Management And Organizational Skills
Knowledge Of Fda Regulations And Guidance Documents
Experience In Regulatory Affairs For Medical Device Or Pharma Industry
Experience In All Stages Of Product Development
Knowledge Of Iso And Other Applicable Global Regulations
Ability To Develop And Implement Regulatory Strategies
Documentation
Strategy
Communication
Quality
Management
Negotiation
Leadership
Reporting
Compliance
Technical
Analysis
Monitoring
Law
Interpersonal
Regulatory
Communication
Leadership
Negotiation
Public Speaking
Time management
Interpersonal Skills
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Director, Regulatory Affairs in Irvine, CA, USA is $123,000 to $174,000. This range reflects the salaries of both entry-level and experienced directors, regulatory affairs in the area. The salary range can vary depending on the specific job duties and qualifications of the individual.
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Edwards Lifesciences (NYSE: EW) is the global leader in the science of heart valves and hemodynamic monitoring.

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