Regulatory Affairs Specialist
Irvine, CA
Schedule:
Standard Office Hours
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.
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