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Senior Specialist, Regulatory Affairs - Critical Care

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Full-Time / SEE
Contact Name: Julia Kern
Phone:   
Fax:  
Email: apply directly online
Salary:

Job Description (up to 200 words): 

The Director, Regulatory Affairs will play a key role in expanding regulatory support and strategies across our Critical Care business. With successful launches of innovative new products and updates to existing technologies, this team is growing rapidly with the promise of new and exciting projects in the US and globally. This role will be responsible for building a team to lead and execute on global regulatory strategies, direct complex project interactions, and ensure the organization is prepared for impending EU Regulations and other emerging issues. 

  • Negotiate and communicate effectively with cross-functional project teams, business partners, management and regulatory agencies
  • Ensure maintenance of compliance associated with CE mark and technical files.
  • Organize project and departmental objectives and delegate effectively.
  • Educate internal and external customers regarding regulatory requirements.
  • Lead Regulatory Affairs staff and directly participate on project teams. 

Job Requirements (up to 200 words):

Requirements:

  • Extensive experience and knowledge of global regulatory requirements for medical devices and a successful regulatory track record in the commercialization of innovative, complex medical devices (510k, IDE/PMA and Class II/III CE approvals)
  • Relevant experience includes Class II and III medical devices, software, algorithms, predictive analytics, monitoring devices, catheters, infusion pumps, and/or ICU monitors.
  • Knowledge of IEC 60601 and software submissions preferred. 

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=013912&lang=en