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Specialist, Regulatory Affairs - Critical Care

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Regulatory Affairs
Contact Name: Patricia Forrest
Phone:
Fax:
Email: apply directly online
Salary:

Job Description

Regulatory Affairs Specialist, we have an excellent opportunity for you to join a high growth, innovative and industry leading organization and advance a career in the Regulatory Affairs function. The successful candidate will represent the Regulatory Affairs function on a variety of Product Development Teams (new and existing) related to the Critical Care business.

  • Under supervision of the RA PM, or  Manager, assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDE-S, IDE Progress Report, Clinical Trial Submission [OUS], 510(k), PMA, PMA-S, PMA Annual Report, Shonin, PLA, CE Mark Design Dossier, CE Mark Technical File, Intercontinental Dossiers, Certificates to Foreign Government, etc.
  • Ensures that existing approvals and documentation are maintained, including SAP Foreign Trade Status. Communicates with in-country RA personnel to facilitate global clearances/approvals.
  • Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies.
  • Monitors, researches and obtains information [such as FOI] on FDA clearances/approvals of competitors, and proactively shares this information with interested parties within Critical Care.
  • Assume regulatory review of labeling, product and process changes and product documentation.



Job Requirements (up to 200 words):

Qualifications/Skills/Experiences:

  • The Regulatory Affairs Specialist role requires a minimum of two years’ experience in the medical device industry.
  • Experience with class I, II, and III devices
  • A Bachelor of Science degree in a scientific or engineering discipline is required, a Master’s degree preferred.
  • General knowledge of global and/or domestic regulatory laws and regulations, industry practices and standards.
  • Basic working knowledge of all U.S. and global regulatory laws and regulations, industry practices and standards (such as ISO 13485, ISO 10993, IEC 60601)
  • Familiarity with UDI.
  • Able to apply general regulatory concepts and principles.
  • Excellent writing and verbal communication skills and experience working on cross-functional project teams and new product development systems.
  • Works well in a team environment
  • Positive and energetic attitude
  • Strong critical thinking, problem-solving, and analytical ability.
  • Required computer skills include intermediate to advanced Microsoft Word and beginning to intermediate Microsoft Excel.
  • Comfortable working in a variety of corporate business management computer systems.

 

Please apply online at:

https://edwards.taleo.net/careersection/jobdetail.ftl?job=011989&lang=en