Job Description

Regulatory Affairs Specialist

Irvine, CA

Schedule: Standard Office Hours, Hybrid PST

Duration: 6-Month Contract

Pay: $44-49.50/ph

The Regulatory Affairs Specialist will support regulatory strategies and registration activities for China and Hong Kong markets. This individual will collaborate closely with global and in-country teams to ensure timely submissions, effective communication, and compliance with medical device regulations.

Job Responsibilities:

In this role, you will manage and support product registrations and regulatory submissions specific to China and Hong Kong. Key responsibilities include:

• Create and maintain regulatory submissions in alignment with regional requirements.
• Track timelines and milestones for submissions and approvals.
• Provide input on regulatory strategies and contingency planning.
• Represent the regulatory function in project teams, offering guidance on China and Hong Kong regulations.
• Collaborate with cross-functional teams (R&D, Quality, etc.) to gather technical information and support documentation.
• Review and analyze technical reports, test data, and engineering drawings.
• Provide regulatory input for labeling, product changes, and renewals.
• Support internal process improvement initiatives.
• Perform other duties as assigned.

Essential Duties and Job Functions:

• Represent regulatory interests in project team meetings.
• Coordinate with in-country regulatory teams to address project status, technical documentation, and compliance requirements.
• Research and review regulatory requirements, standards, and guidelines applicable to Class II and Class III medical devices in China and Hong Kong.
• Ensure timely and accurate submission of registration dossiers.
• Maintain effective communication channels across global teams.

Knowledge & Skills:

• Fluency in Mandarin Chinese and English is required.
• Strong knowledge of China NMPA medical device regulations and submission processes.
• Experience reviewing technical documentation (e.g., test reports, drawings).
• Familiarity with U.S. regulatory requirements to facilitate global coordination.
• Excellent organizational, analytical, and communication skills.
• Ability to work effectively with cross-functional and international teams.
• High ethical standards and integrity are mandatory.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Business acumen and presentation skills are a plus.

Work Schedule and Environment:

• Standard office hours; limited overtime expected.
• Hybrid work model preferred (minimum 1 day onsite per week).
• Remote candidates must be available in Pacific Standard Time (PST) to align with Asia-based teams.
• Minimal travel required.

Education & Experience:

• Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Microbiology) or equivalent.
• 5-7 years of experience in regulatory affairs, specifically with China and/or Hong Kong medical device registrations.

Job Tags

Similar Jobs