Sr. Regulatory Affairs Specialist Job at Intellectt Inc, Irvine, CA

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  • Intellectt Inc
  • Irvine, CA

Job Description

Role: Sr. Regulatory Affairs Specialist

Location: Irvine, CA – 92606

Key Responsibilities:

  • Prepare and support regulatory submissions for China and Hong Kong markets, ensuring protection of proprietary information.
  • Track submission timelines , milestones , and contribute to regulatory strategy development .
  • Provide regulatory insights and contingency planning guidance based on local and global regulations.
  • Collaborate with cross-functional teams (manufacturing, product development, business units) to ensure alignment with regional regulatory requirements.
  • Assist with registration planning , labeling content reviews , and guidance on regulatory process improvements .
  • Other duties as assigned by leadership.

Must-Have Skills:

  • Fluency in Mandarin Chinese (verbal and written).
  • Proven experience with China regulatory submissions .
  • Strong grasp of global medical device regulations , particularly for Class II/III products.
  • Working knowledge of new product development systems .
  • Excellent communication , problem-solving , and organizational skills.
  • Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel).
  • Ability to manage multiple priorities in a fast-paced environment and collaborate across departments.
  • Attention to detail and ability to interact at all organizational levels.

Education & Experience:

  • Bachelor’s Degree in a scientific discipline (Biology, Chemistry, Microbiology, etc.) or equivalent.
  • 5–7 years of regulatory affairs experience preferred.
  • Must have direct experience with China medical device registration.

Job Tags

Local area,

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