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Senior Specialist, Regulatory Affairs - Transcatheter Heart Valve

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 

  • Support conversion of CE mark products from MDD to MDR requirements.  Interpret and implement plans to assure compliance with the MDR.  Develop requirements into internal procedures for new product development. 
  • Represent the regulatory function on manufacturing and product development teams. Present alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
  • Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans.
  • Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and documents milestone achievements for inclusion in regulatory submissions.  May interact with regulatory agencies as part of submission review and on-site audit support. (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files).
  • Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process.
  • Review labeling content product and process changes, and product documentation to assure compliance, consistency, and accuracy. 

Job Requirements: 

  • A Bachelor’s degree in a related field is required; a scientific discipline is preferred.
  • A minimum of five years of related experience is required with a Bachelor’s degree, OR, a minimum of three years of related experience is required with a Master’s degree. 
  • Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices.
  • Full knowledge and understanding of global regulatory requirements for new products or product changes.
  • Full knowledge of new product development systems.
  • Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel.
  • Excellent written and verbal communication skills including negotiating and relationship management skills.
  • Excellent problem-solving, organizational, analytical and critical thinking skills.
  • Good leadership skills and ability to influence change.
  • Strict attention to detail.
  • 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 inter-departmental teams and key contact representing the organization on contracts or projects.
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
     

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=016849&lang=en