Regulatory Affairs Specialist

2 weeks ago


California, United States Edwards Lifesciences Full time
Make a Meaningful Difference in Critical Care

At Edwards Lifesciences, we're committed to creating a world where every patient who should be monitored will be monitored with smart technology. As a Regulatory Affairs Specialist, you'll play a critical role in helping us achieve this vision.

Your Impact
  • Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements.
  • Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance.
  • Provide guidance on regulatory requirements necessary for strategic and contingency planning.
  • Prepare and oversee documentation packages for submission to global regulatory agencies.
What We're Looking For
  • Bachelor's Degree in a related field and 5 years of previous related experience.
  • Or Master's Degree in a related field and 3 years of previous related experience.
  • Coursework, seminar, and/or other formal government and/or trade association training.

We offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $88,000 to $124,000 (highly experienced).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

We are committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.



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