Regulatory Affairs Specialist - Heart Valve Therapy

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Irvine, CA
Job Type
Direct Hire
Jan 09, 2018
Job ID
GR Identifier: $Medd

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As the Regulatory Affairs Specialist, you will focus on supporting US and international submissions and post market regulatory activities.
Responsibilities include:
  • Responsible for Post-Market regulatory compliance activities, including annual reports
  • Prepare US and/or international submissions. Interacts with FDA and other regulatory bodies for submissions and projects.
  • Responsible for review of product/process change requests and assess the impact of the change on US and international regulatory strategy/submissions.
  • Support RA management and team leaders on product development and commercialization team activities and submissions related to Heart Valve Therapies products.
  • Monitor proposed and current US and EU regulations, guidance & standards, and evaluate the impact of such regulations and guidance on assigned products/projects
  • Control and maintain regulatory records
  • Additional Regulatory Affairs related projects as assigned.
Education/skills requirements:
  • A minimum of 3 years’ experience and Bachelor’s degree is required. A science or engineering degree is strongly preferred. Medical device experience in other areas, may be considered.
  • Experience in preparing US and EU product submissions are required.
  • Must be competent in applying the appropriate regulatory requirements for product changes.
  • Must possess a strong working knowledge of US /EU regulations that affect Class II and/or Class III devices.
  • Must have strong written and verbal communication skills, and have experience working on cross functional project.
  • Strong ability to problem solve and apply analytical thinking is required.