Intellectt Inc

APAC Regulatory Specialist II

Intellectt Inc Alameda, CA
Intellectt Inc

APAC Regulatory Specialist II

Intellectt Inc Alameda, CA
2 months ago
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Role: Regulatory Specialist II

Location: Alameda, CA - 94502

Duration: 12 Months

Job Description

  • Responsible for regulatory activities, including product registrations, impact assessment, etc.
  • Understand country-specific requirements and deliver those to internal stakeholders, including
  • product management, engineering, labeling, etc., for product registration and change planning
  • Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projectsand discuss the issues to solve.
  • Plan and execute the given tasks proactively in a timely manner.
  • Report the status to a manager weekly.
  • Keep the training records up to date to do the tasks. Othe
  • Knowledge of International Standards, such as ISO13485, IEC60601
  • Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.
  • Knowledge of Agile, SharePoint, MS

  • Seniority level

    Associate

  • Employment type

    Full-time

  • Job function

    Legal

  • Industries

    Staffing and Recruiting

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