Regulatory Affairs Specialist in Alameda, CA

Position is for 1 year with the possibility of extensions.

Onsite only in Alameda CA.

Looking for Local to Bay Area only.
 

Should be able to join early calls and meetings

APAC regulatory submissions in Medical Devices or Pharmaceutical industries. (China, Korea, Australia , Singapore, Thailand, Japan APAC countries)

RA specialist with APAC knowledge and exp needed

Real regulatory submission experience – writing submissions.

Bachelors or masters degree needed

• Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.
• Should know how to navigate information, product information
• Will check internal documents
• Bachelors or masters degree with 5 yrs. exp needed
• Any science background
• APAC regulatory work exp needed
• Medical Device industry exp needed
• 5 yrs. exp needed
• Will not communicate with local health authority
• communicate with internal and external stakeholders
• Good understanding of International Standards, such as ISO13485, IEC60601.
• Pharma regulatory affairs exp will also work

Manager is looking for:

Education:

• Bachelors degree
• 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.

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