Regulatory Specialist II
3 weeks ago
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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