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Regulatory Specialist II
Alameda, CA
Job Description
Job Title: Regulatory Specialist II
Location: Alameda, CA (94502)
Duration: 12 Months
Shift: 8 AM to 5 PM
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)
Daily tasks/duties and department interactions: prep submissions, regulatory strategy, review change control, other assigned tasks. Interacting with QA, Labeling, Engineer, PMO. Etc.
Other
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
Location: Alameda, CA (94502)
Duration: 12 Months
Shift: 8 AM to 5 PM
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.
- level/certifications: BS, MS
- Understand technical sections (risk management, product change control, biological evaluation) Years of experience required: 5+
Daily tasks/duties and department interactions: prep submissions, regulatory strategy, review change control, other assigned tasks. Interacting with QA, Labeling, Engineer, PMO. Etc.
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.
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
Open
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