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Sr Spec, Regulatory Affairs

Company: Planet Pharma
Location: Irvine
Posted on: November 25, 2022

Job Description:


  • Support the Regulatory Intelligence program to help identify and meet Regulatory changes as early as possible that may impact Edwards' business globally through:
  • Creating strategies and contingency planning with respect to worldwide Regulatory requirements, including assessing the impact of proposed and current global regulations and proposing solutions for expediting approvals
  • Creating gap assessments for changes in regulations/standards (Japan and UK)
  • Providing guidance on the implementation of various Regulatory process improvement projects and collaborating directly with key stakeholders in all business units and functional groups as well as Edwards' international counterparts to accelerate market access routes and ensure compliance
  • Guide Business Unit RA teams based on Regulatory changes and compliance timelines
  • Facilitate and/or lead teleconference and in-person meetings with key stakeholders of various positions including international partners
  • Candidate must be comfortable speaking in meetings.
  • Provide guidance on process improvement/remediation projects based on prior experience and responses from international affiliates
  • Provide support to supervisor as needed.

    • Expertise in utilizing Microsoft Office Suite including Word, PowerPoint and Excel to support highly-effective presentations, reporting, communications, assessments, etc.
    • Proficiency in hosting, presenting and troubleshooting teleconferences via Microsoft Teams including professional camera presence
    • Effective written and verbal communication skills with people of various international backgrounds and good interpersonal relationship skills
    • Strong problem solving, organizational, analytical and critical thinking skills
    • Manage competing priorities in a fast-paced environment
    • Strict attention to detail
    • Ability to interact professionally with all organizational levels
    • Build and sustain stable working relationships internally
    • Must be able to work in a team environment, including immediate supervisor and other team members
      • Bachelor's degree required; scientific discipline preferred
      • Minimum five years of RA experience within medical devices required with a bachelor's degree, or, minimum three years of RA experience within medical devices required with a Master's degree - preferred
      • Good knowledge and understanding of global regulations relevant to medical devices (e.g. product registration, UDI, labeling) from health authorities including: FDA, NMPA, MHRA, EU Commission
      • Good knowledge and understanding of global Regulatory requirements for new products or product changes
        Good knowledge of new product development systems
        ***Salary will be commensurate with experience***

Keywords: Planet Pharma, Irvine , Sr Spec, Regulatory Affairs, Other , Irvine, California

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