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Regulatory Specialist II (APAC/Regulatory Submissions)

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Job Description

Job Description

Education: Bachelor s degree

Experience Background (Any): APAC regulatory submissions in Medical Devices or Pharmaceutical industries.

Job Description (Expectation):

Responsible for regulatory activities, including product registrations, regulatory 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 interactions between RA and other departments to pre/post-market RA activities.

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.

Able to manage time and projects.

Able to complete the tasks with minimum supervision.

Company Description
Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.

Company Description

Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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