Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Job Title: Regulatory Affairs Specialist II
Location - 2901 Harbor Bay Parkway, Alameda, CA 94502
Duration – 12 Months
Pay rate - $59/hr
Years of Experience: At least 5 years
Location: On-Site (5-days a week)
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.
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.
Job Type: Contract
Pay: $21.00 - $59.00 per hour
Benefits:
Schedule:
Ability to Commute:
Ability to Relocate:
Work Location: In person
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0 Regulatory Affairs Specialist jobs found in Richmond, CA area