Sr. Regulatory Affairs Specialist

International Erosion Control Association; Irvine (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

A leading company seeks a Sr. Regulatory Affairs Specialist in Irvine, CA to manage regulatory submissions for China and Hong Kong, providing insights based on global medical device regulations. The role requires fluency in Mandarin, a scientific degree, and several years of regulatory experience, focusing on ensuring compliance and strategic planning across departments.

Qualifications

• 5–7 years of regulatory affairs experience preferred.
• Direct experience with China medical device registration required.
• Strong grasp of global medical device regulations for Class II/III products.

Responsibilities

• Prepare and support regulatory submissions for China and Hong Kong.
• Collaborate with cross-functional teams for regulatory alignment.
• Track submission timelines and contribute to regulatory strategy.

Skills

Fluency in Mandarin Chinese

Communication

Problem-Solving

Organizational

Attention to Detail

Education

Bachelor’s Degree in a scientific discipline

Tools

Microsoft Office Suite

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.