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Regulatory Specialist II
$92k-120k (estimate)
Full Time 6 Days Ago
Save

TekOne IT Services Pvt. Ltd. is Hiring a Regulatory Specialist II Near Alameda, CA

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 projects and 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.
  • Able to start projects immediately after internal system training. Other
  • 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 Office, and other software to increase work efficiency.
  • Ability to manage time and projects.

Job Summary

JOB TYPE

Full Time

SALARY

$92k-120k (estimate)

POST DATE

09/11/2024

EXPIRATION DATE

03/05/2025

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TekOne IT Services Pvt. Ltd.
Full Time
$89k-108k (estimate)
1 Day Ago
TekOne IT Services Pvt. Ltd.
Full Time
$88k-105k (estimate)
1 Day Ago
TekOne IT Services Pvt. Ltd.
Full Time
$87k-113k (estimate)
1 Day Ago

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