Regulatory Specialist Ii (Apac)

Description

Home Search Jobs Job Description Regulatory Specialist II (APAC)

Contract: Alameda, California, US

Salary: $55.00 Per Hour

Job Code: 352082

End Date: 2024-09-25
Days Left: 10 days, 3 hours left

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To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - ****** or give me a call at (425) 523-1648. Thank you!

Pay Range - $45 to $55/hr. (negotiable) Job Description: Job Roles & Responsibilities: Experience Background (Any): 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. Job Requirement Regulatory Specialist Regulatory Affairs APAC ISO13485 IEC60601 TGA NMPA PMDA MFDS HSA TFDA FDA MOH regulatory submissions Medical Devices Pharmaceutical Reach Out to a Recruiter Recruiter Email Phone Chitrank Rastogi ****** 4255231648 Apply Now