Collabera
Regulatory Specialist II (APAC)
Collabera, Alameda, California, United States, 94501
Description
HomeSearch JobsJob Description
Regulatory Specialist II (APAC)
Contract: Alameda, California, US
Salary: $55.00 Per Hour
Job Code: 352082
End Date: 2024-09-25Days Left: 1 days, 3 hours left
Apply
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 - chitrank.rastogi@collabera.com 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 SpecialistRegulatory AffairsAPACISO13485IEC60601TGANMPAPMDAMFDSHSATFDAFDAMOHregulatory submissionsMedical DevicesPharmaceuticalReach Out to a RecruiterRecruiterEmailPhoneChitrank Rastogichitrank.rastogi@collabera.com4255231648
Apply Now
HomeSearch JobsJob Description
Regulatory Specialist II (APAC)
Contract: Alameda, California, US
Salary: $55.00 Per Hour
Job Code: 352082
End Date: 2024-09-25Days Left: 1 days, 3 hours left
Apply
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 - chitrank.rastogi@collabera.com 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 SpecialistRegulatory AffairsAPACISO13485IEC60601TGANMPAPMDAMFDSHSATFDAFDAMOHregulatory submissionsMedical DevicesPharmaceuticalReach Out to a RecruiterRecruiterEmailPhoneChitrank Rastogichitrank.rastogi@collabera.com4255231648
Apply Now