Regulatory Affairs Specialist Job at Hydrogen Group, Irvine, CA

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  • Hydrogen Group
  • Irvine, CA

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

Contract work, 1 day per week,

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