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Manager, Regulatory Affairs (Sustaining) - Transcatheter Heart Valve

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Full-Time/SEE
Contact Name: Julia Kern
Email: apply directly online (see below)

Job Description

This is an excellent opportunity to join a high growth, innovative and industry-leading organization and advance a career in the Regulatory Affairs function. 

  • Develop and plan multiple regulatory affairs projects and activities including analysis of situations or data. Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements and provide alternatives when appropriate.
  • Review and approve protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation.
  • Provide direction and guidance to project teams to execute tactical regulatory affairs projects and/or initiatives. Includes preparation and oversight of larger documentation packages for submission to regulatory agencies. 
  • Identify and evaluate regulatory affairs process improvement and/or course correction/course alignment opportunities
  • Develop strategies and contingency plans for projects, including those that are most complex and challenging
  • May anticipate and advise on future regulatory trends and direction, and recommend preemptive approaches for company regulatory compliance
  • May act as a key member in RA committee (e.g., AdvaMed, standards/committee) and provide input in the development of standards/regulations that affect the Medical Device industry
  • May review promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy 

Job Requirements: 

  • A Bachelor's degree is required; scientific discipline is preferred. A Master’s degree is preferred
  • A minimum of 10 years of previous related experience is required; With a master’s degree, 8 years of previous related experience is required; Experience preparing domestic and international product submissions is preferred
  • Expert knowledge and understanding of global regulations relevant to Class II and/or Class III medical devices is required
  • Recognized as an expert in own area with specialized depth within the organization
  • Coursework, seminars, and/or other formal government and/or trade association training required
  • Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
  • Expert knowledge and understanding of global regulatory requirements for new products or product changes.
  • Expert knowledge of new product development systems
  • Strong leadership skills and ability to influence change
  • Strict attention to detail
  • Ability to manage competing priorities in a fast paced environment
  • Represents leadership on projects within a specific area interfacing with project managers and regulatory affairs team
  • Consult in project setting within specific regulatory affairs area
  • Provides regulatory affairs leadership to outsourcing partners on a task level, and may participate on small scale RFP

Please apply online at: