Edwards Lifesciences

Director, Regulatory Affairs

Edwards Lifesciences

Irvine, CA, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

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

Where is this job?
This job is located at Irvine, CA, USA
Job Qualifications
  • 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

Required Skills
  • Documentation

  • Strategy

  • Communication

  • Quality

  • Management

  • Negotiation

  • Leadership

  • Reporting

  • Compliance

  • Technical

  • Analysis

  • Monitoring

  • Law

  • Interpersonal

  • Regulatory

Soft Skills
  • Communication

  • Leadership

  • Negotiation

  • Public Speaking

  • Time management

  • Interpersonal Skills

  • Critical thinking

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

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.

Additional Information
Edwards Lifesciences is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedMarch 30th, 2023
Apply BeforeMay 22nd, 2025
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About Edwards Lifesciences

Edwards Lifesciences (NYSE: EW) is the global leader in the science of heart valves and hemodynamic monitoring.

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