Regulatory Affairs Specialist 3 Job at MILLENNIUMSOFT, Irvine, CA

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  • MILLENNIUMSOFT
  • Irvine, CA

Job Description

Roles & Responsibilities

  • Support US and EU regulatory submissions, ensuring protection of proprietary information
  • Track regulatory timelines and document milestone achievements
  • Assess regulatory impact and contribute to regulatory strategy development
  • Review, collaborate on, and approve change requests and change notifications
  • Provide guidance to regulatory teams on:
    • New and renewal registrations
    • Product and process changes
    • Labeling content and compliance
  • Collaborate cross-functionally with internal teams
  • Perform additional duties as assigned by leadership
Experience Required
  • 5-7 years of hands-on experience in Regulatory Affairs
  • Experience supporting medical devices (Class II and/or Class III)
  • Exposure to global regulatory submissions and compliance requirements
Skills & Certifications
  • Strong knowledge of US and EU regulatory frameworks
  • Understanding of global regulations for new products and product changes
  • Excellent written and verbal communication skills
  • Strong analytical, problem-solving, and critical-thinking abilities
  • High attention to detail and documentation accuracy
  • Ability to manage multiple priorities in a fast-paced environment
  • Proficient in Microsoft Word, Excel, and PowerPoint
  • Strong interpersonal and stakeholder management skills
  • Team-oriented with cross-functional collaboration experience
Eligibilities & qualifications
  • Bachelor's Degree or equivalent in a scientific discipline

    (Biology, Microbiology, Chemistry, or related field)
  • Relevant regulatory coursework, seminars, or formal training preferred

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