Regulatory Affairs Specialist II

2 weeks ago


Alameda, United States Select Source International Full time $45 - $60
Job DescriptionJob Description

Role: Regulatory Specialist II

Duration: 12 Months

Location: 2901 Harbor Bay Parkway, Alameda, CA 94502

Please read before applying.

  • This is 100% Onsite role and candidates need to relocate on their own expenses.
  • Also, Experience with APAC along with submission to TGA, NMPA, PMDA, MFDS, HSA, TFDA regulatory bodies is must.

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.
Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.

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