Regulatory Affairs Specialist Job at Hydrogen Group, Irvine, CA

UmFSQXpxZjkzazZuL1V0TGdBL0E3WFhC
  • 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,

Similar Jobs

Richard, Wayne & Roberts

Information Technology Manager Job at Richard, Wayne & Roberts

 ...Our client is seeking a Manager, Information Technology Site Services to lead IT support operations across LNG plant locations. This role oversees site support personnel and ensures exceptional service for troubleshooting hardware, software, and telecom systems.... 

Robinson & Henry, P.C.

Family Law Attorney Job at Robinson & Henry, P.C.

 ...lawyers seldom obtain. As one of Colorados premier full-service law firms, we specialize in Family Law. Here, youll help clients...  ...Bar Prior courtroom experience is required Experience in criminal defense is a HUGE plus A team player who values collaboration... 

EPM Scientific

Senior Director, Strategy Job at EPM Scientific

 ...from strategy through presentation Direct cross-functional teams, manage budgets of projects with clients ranging from small to fortune 500 Work closely with agency leadership to manage projects through proposal, market research, message development, and advisory... 

All American Roof Pros

Gutter Technician Job at All American Roof Pros

 ...Job Posting for Gutter Technician at All American Roof Pros Job Description All American Roof Pros, a leader in the roofing industry, is excited to announce an opening for a Gutter Technician. This is an excellent opportunity to develop your skills in a dynamic... 

Starbucks

Store Manager - New Store Opening-Prudenville, MI. Job at Starbucks

**Store manager**Job Summary and MissionThis job contributes to Starbucks success by leading a team of managers and partners to deliver the _Roastery Experience_ for our customers and partners. The store manager is required to regularly and customarily exercise discretion...