Regulatory Affairs Specialist- Suzhou
Regulatory Affairs Specialist- Suzhou
Posted on :
22-08-2025
Employer Active
1 Vacancy
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Job Description
Plan and execute project registration activities according to the registration (and renewal) strategy registration project plan.
Prepare the registration dossier and product technical requirement.
Work closely with project team to ensure registration activities meeting project timeline.
Define priorities together with line manager on assigned projects or across multiple projects for RA and cross functional project team members.
Support the international registration by providing outstanding Suzhou documents on time.
Support the manufacturing and R&D activities and review related changes on time.
Support the product transfer and complete the regulatory action including the classification made in and timeline with the support from global RA.
Support the raw material and packaging material localization projects and other global projects to provide the regulatory impact assessment with the support from global RA.
Support the internal/external audit. Provide regulatory guidance to team.
/
Maintain the relationships with internal partners including global RA local quality R&D and Manufacture. Effectively communicate with these functional partners.
Identify evaluate and interpret new policies and regulations for product development and registration.
Assist in providing consultation and direction regarding regulation and policy trends.
Take the initiative and lead the discussion in standard improvement etc. to support JnJ project and business.
Understand and adherence to J&J Credo and value of Credo based decision. Execute departmental strategy.
Keep learning company related technical policy product knowledge business process to develop professional skill and work efficiency.
Strictly maintain confidential information and intellectual property (IP) includes product development information designs manufacture process trade secrets government reporting and legal matters sales volumes and marketing strategies.
/
Familiar with China and oversea regulations (if applicable) of medical device and registration process having knowledge of product design process product feature product test and manufacture process.
Good communication skills to influence internal and external decisions by effectively utilize both written and oral communications or through presentations.
Exhibits effective time management project management skills and risk management skills.
Exhibits problem solving skill with strategic thinking and critical thinking demonstrated excellent execution capability.
Honest positive diligent and dedicated with excellent team spirit highly disciplined.
Curiosity and passion for new regulation policy and technologies.
Have medical device quality knowledge (GMP GDP etc).
GMPGDP
Fluent in both Mandarin and English.
Prepare the registration dossier and product technical requirement.
Work closely with project team to ensure registration activities meeting project timeline.
Define priorities together with line manager on assigned projects or across multiple projects for RA and cross functional project team members.
Support the international registration by providing outstanding Suzhou documents on time.
Support the manufacturing and R&D activities and review related changes on time.
Support the product transfer and complete the regulatory action including the classification made in and timeline with the support from global RA.
Support the raw material and packaging material localization projects and other global projects to provide the regulatory impact assessment with the support from global RA.
Support the internal/external audit. Provide regulatory guidance to team.
/
Maintain the relationships with internal partners including global RA local quality R&D and Manufacture. Effectively communicate with these functional partners.
Identify evaluate and interpret new policies and regulations for product development and registration.
Assist in providing consultation and direction regarding regulation and policy trends.
Take the initiative and lead the discussion in standard improvement etc. to support JnJ project and business.
Understand and adherence to J&J Credo and value of Credo based decision. Execute departmental strategy.
Keep learning company related technical policy product knowledge business process to develop professional skill and work efficiency.
Strictly maintain confidential information and intellectual property (IP) includes product development information designs manufacture process trade secrets government reporting and legal matters sales volumes and marketing strategies.
All work will be carried out in accordance with company policies and procedures. Ability to comply with the Quality Management System Quality Management Policy Quality Goals and applicable laws and regulations.
B.S. or above in medical material mechanical/biomechanical engineering or pharma./
Familiar with China and oversea regulations (if applicable) of medical device and registration process having knowledge of product design process product feature product test and manufacture process.
Good communication skills to influence internal and external decisions by effectively utilize both written and oral communications or through presentations.
Exhibits effective time management project management skills and risk management skills.
Exhibits problem solving skill with strategic thinking and critical thinking demonstrated excellent execution capability.
Honest positive diligent and dedicated with excellent team spirit highly disciplined.
Curiosity and passion for new regulation policy and technologies.
Have medical device quality knowledge (GMP GDP etc).
GMPGDP
Fluent in both Mandarin and English.
Required Experience:
Unclear Seniority
Employment Type
Full Time
Key Skills
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