Immediate hiring for Regulatory Specialist II
Location
Alameda, CA | United States
Job description
Role: Regulatory Specialist II
Location: Alameda, CA - 94502
Duration : 12 Months
Experience Background (Any): Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assurance,
SW Engineering, APAC regulatory submission, or APAC-related work under Quality
Assurance/Engineering.
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.
List any preferred requirements that would stand out on a resume:
- understand technical sections (risk management, product change control, biological evaluation)
- Years of experience required : 5+
- Required education level/certifications : BS, MS
- Daily tasks/duties and department interactions:
- prep submissions, regulatory strategy, review change control, other assigned tasks.
- Interacting with QA, Labeling, Engineer, PMO. Etc.
- Description of work environment/department:
- Assigned Desk, quiet area but dynamic work, Occasional night calls (after 5PM) with Affiliates.
- Preferred interview method (one step or two step/phone or video conference): video interviews- two step interviews
Other:
- Knowledge of International Standards, such as ISO13485, IEC 60601.
- 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 tags
Salary
