Regulatory Specialist Ii

Description

Home Search Jobs Job Description Regulatory Specialist II

Contract: Alameda, California, US

Salary: $55.00 Per Hour

Job Code: 352037

End Date: 2024-08-28
Days Left: 2 days, 3 hours left

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Pay range: $50 to $55 per hour

Experience Background: APAC regulatory submissions in Medical Devices or Pharmaceutical industries. Job Description (Expectation): 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. Strict to work 40hrs per week Job Requirement Regulatory Affairs APAC Asia-Pacific Asia Pacific Medical device Pharmaceutical Biotechnology Health care Healthcare Reach Out to a Recruiter Recruiter Email Phone Harish Yadav ****** 9739468912 Apply Now