Position: Regulatory Affairs Specialist
Location: Alameda, CA
Duration: 12+ Months

Key Responsibilities:

• Responsible for regulatory activities including product registrations and impact assessments.
• Understand country-specific requirements for product registration and change planning, and communicate these requirements to internal stakeholders such as product management, engineering, and labeling teams.
• Maintain weekly communication with affiliate Regulatory Affairs (RAs) in different time zones to manage ongoing projects and resolve issues.
• Plan and execute tasks proactively and in a timely manner.
• Provide weekly status reports to the manager.
• Keep training records updated and complete internal system training to start projects immediately.

Experience Required:

• 2-5 years of regulatory experience or 2 years of relevant industrial experience with a quality, product- development/support, or scientific affairs function.
• Experience with APAC regulatory submissions in Medical Devices or Pharmaceutical industries preferred.

Skills and Knowledge:

• Knowledge of International Standards (e.g., ISO13485, IEC60601)
• Proficiency in Agile, SharePoint, MS Office, and other software to increase work efficiency.
• Strong time and project management skills.