Regulatory Specialist II

3 weeks ago


Alameda, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

Job Tittle: Regulatory Specialist II

Location: Alameda, CA 94502 (Onsite)

Rate: $59.00/hr. on w2

Duration: 1 year with the possibility of extensions

Shift Time: 8:00 AM to 5:00 PM


Job Description:


Manager is looking for:

Education:

  • Bachelor’s degree
  • Minimum of 5 years exp.
  • APAC regulatory submissions


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.
  • Strict to work 40hrs per week.


TOP 3 Skills:

  • Analytical
  • Knowledge about requirements for APAC specifically
  • Ability to manage projects and time management.


Interview Process:

  • 2 interviews - Video Conferences of 1 with the manager and maybe a 2nd.



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