Senior Regulatory Affairs Specialist

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$55.03/hr - $55.03/hr

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Job Title:

Senior Regulatory Affairs Specialist

Pay Rate: $50 to $55.03/HR

Duration: 6 months

Location:

Irvine, CA/Remote (9 am to 6 pm PST time zone due to frequent later afternoon meetings with Asia regions)

Our Client is a Global medical device Manufacturer.

We are looking for a Senior Regulatory Affairs Specialist to complete and maintain China and Hong Kong regulatory approvals and clearances of assigned products.

• Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by China and Hong Kong affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, and prioritize submissions
• Participate in providing guidance on strategies and contingency planning with respect to China and Hong Kong regulatory requirements, including assessing the impact of proposed and current global regulations and proposing suggestions for expediting approvals.
• Participate in representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.
• Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content. and guidance on process improvement projects, based on prior experience and responses from affiliates.
• Represent regulatory in the project team meetings, discussing project status and technical requests with China/Hongkong regulatory team, researching technical testing reports, drawings and communicate with R&D/ Quality teams
• Other incidental duties assigned by Leadership.

Must-have skills:

• Review of technical reports and submission dossiers, clear communication (English and Mandarin), and organization skills.

Requirements:

• Bachelor's Degree or equivalent in a scientific discipline (e.g., Biology, Microbiology, Chemistry)
• 5-7 years of experience preferred, experience with China regulatory registration required.
• Several years of experience in supporting China medical device registrations, type testing, and design changes.
• Understanding of China NMPA regulations,
• Experiences in type testing and China registrations, solid knowledge of US registration to quickly identify the technical information needed

Additional Skills:

• Fluency in Mandarin Chinese
• Coursework, seminars, and/or other formal government and/or trade association training required
• Proven expertise in Microsoft Office Suite, including Word, PowerPoint, and Excel
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical, and critical thinking skills
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Solid knowledge and understanding of global regulatory requirements for new products or product changes.
• Solid knowledge of new product development systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including inter-departmental teams, and represent the organization on specific projects
• Ability to build productive internal/external working relationships
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others, as well as to the protection of the environment and prevention of pollution under their span of influence/control

• Seniority level
  
  Not Applicable

• Employment type
  
  Full-time

• Job function
  
  Health Care Provider and Other
• Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Hospitals and Health Care

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