Job Description

Role: Sr. Regulatory Affairs Specialist

Location: Irvine, CA – 92606

Key Responsibilities:

• Prepare and support regulatory submissions for China and Hong Kong markets, ensuring protection of proprietary information.
• Track submission timelines , milestones , and contribute to regulatory strategy development .
• Provide regulatory insights and contingency planning guidance based on local and global regulations.
• Collaborate with cross-functional teams (manufacturing, product development, business units) to ensure alignment with regional regulatory requirements.
• Assist with registration planning , labeling content reviews , and guidance on regulatory process improvements .
• Other duties as assigned by leadership.

Must-Have Skills:

• Fluency in Mandarin Chinese (verbal and written).
• Proven experience with China regulatory submissions .
• Strong grasp of global medical device regulations , particularly for Class II/III products.
• Working knowledge of new product development systems .
• Excellent communication , problem-solving , and organizational skills.
• Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel).
• Ability to manage multiple priorities in a fast-paced environment and collaborate across departments.
• Attention to detail and ability to interact at all organizational levels.

Education & Experience:

• Bachelor’s Degree in a scientific discipline (Biology, Chemistry, Microbiology, etc.) or equivalent.
• 5–7 years of regulatory affairs experience preferred.
• Must have direct experience with China medical device registration.

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