Senior Regulatory Affairs Specialist

Infosoft Health; Irvine (CA); Hybrid; USD 100,000 - 125,000; Full time

Job summary

A leading company in the medical device industry is seeking a Senior Regulatory Affairs Specialist in Irvine, CA. This role involves managing regulatory submissions and ensuring compliance with China and Hong Kong regulations. The ideal candidate will have extensive experience in regulatory affairs and fluency in Mandarin, alongside strong analytical and communication skills.

Qualifications

• 5-7 years of experience preferred with China regulatory registration.
• Fluency in English and Mandarin.
• Experience with supporting China medical device registrations.

Responsibilities

• Create regulatory submissions for China and Hong Kong.
• Provide guidance on regulatory strategies.
• Represent regulatory in project team meetings.

Skills

Communication

Organization Skills

Analytical Skills

Critical Thinking

Problem Solving

Education

Bachelor's Degree or equivalent in a scientific discipline

Tools

Microsoft Office Suite

Job description

Job Title:Senior Regulatory Affairs Specialist
Pay Rate: $50 to $55.03/HR
Duration: 6 months
Location: Irvine, CA/Remote (9 amto 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 aSenior Regulatory Affairs Specialistto 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 the China/Hong Kong regulatory team, researching technical testing reports, drawings and communicate with R&D/ Quality teams
• Other incidental duties assigned by Leadership.

Must-have skills:

• China NMPA medical device requirements,
• 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