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Senior Specialist, Regulatory Affairs

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

Job Description: 

 

Edwards Lifesciences is searching for a Senior Specialist to support our Corporate Regulatory Affairs team. This individual will provide expertise, analyses, coordination and contingency planning for the MDR Implementation Program. 

Responsibilities include: 

  • Analyze and streamline expert information related to EU MDR
  • Provide expertize to MDR Implementation Teams on different regulatory subjects, coordinating regulatory information between teams
  • Represent Regulatory Affairs Corporate in different MDR Implementation teams and the MDR Core Team
  • Represent Regulatory Affairs Corporate in providing guidance on strategies and contingency planning with respect to EU MDR regulatory requirements, including assessing impact and proposing suggestions
  • Provide support to MDR Program Owner as needed
  • Represent Regulatory Affairs Corporate on a variety of global regulatory initiatives and provide regulatory guidance to business units as well as the international counterparts
  • Develop timelines and document milestone achievements
  • Support different Regulatory Affairs Corporate activities
  • Provide guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations

 

Job Requirements (up to 200 words): 

  • A minimum of five years’ experience in the medical device industry is required
  • A Bachelor’s degree is required, a Master’s degree is preferred
  • Knowledge of the New EU MDR is preferred/desired
  • Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
  • Good written and verbal communication skills and interpersonal relationship skills
  • Good problem-solving, organizational, analytical and critical thinking skills
  • Good knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
  • Good knowledge and understanding of global regulatory requirements for new products or product changes.
  • Strict attention to detail
  • European regulations experience is required
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
  • Ability to build stable working relationships internally

 

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=014856&lang=en