Senior RA specialist_MD
- Product registration related including new, extension and changes:
• Document requirement
• Sample ordering and type testing
• Dossier preparation
• Submission
• Following up CMDE evaluation procedures
• Solving various problems in whole process
• Maintaining database like RA database, MDRiM
• Filing dossiers with consistent requirement
o Ensure to obtain the regulatory permits on time, in support of the organization’s business requirements
o Having a good and consistent communication with local marketing and know well the business plan especially product launch plan, gain effective support during product registration process
o Establish working relationship with officials and experts in authorities, good communication and negotiation with officials and experts to guarantee smooth registration
o Supporting Chinese IFU and Labeling projects, copy reviews, and other related projects
o Provide monthly report and analysis about latest registration status
o Develop Regulatory Strategy and Plan for Chartered R&D Initiatives from Sourcing companies and partner with the project team to ensure the approval at each review gate.
o Being sensitive to capture the regulatory information to support company policy statement and contribute the constructive option for regulatory environment shaping.
• Document requirement
• Sample ordering and type testing
• Dossier preparation
• Submission
• Following up CMDE evaluation procedures
• Solving various problems in whole process
• Maintaining database like RA database, MDRiM
• Filing dossiers with consistent requirement
o Ensure to obtain the regulatory permits on time, in support of the organization’s business requirements
o Having a good and consistent communication with local marketing and know well the business plan especially product launch plan, gain effective support during product registration process
o Establish working relationship with officials and experts in authorities, good communication and negotiation with officials and experts to guarantee smooth registration
o Supporting Chinese IFU and Labeling projects, copy reviews, and other related projects
o Provide monthly report and analysis about latest registration status
o Develop Regulatory Strategy and Plan for Chartered R&D Initiatives from Sourcing companies and partner with the project team to ensure the approval at each review gate.
o Being sensitive to capture the regulatory information to support company policy statement and contribute the constructive option for regulatory environment shaping.
3-4 years RA experience in medical devices
Medical or related education background and knowledge
Good communication skills in both Chinese and English
Effective time management skills
Well computer operation skills
Medical or related education background and knowledge
Good communication skills in both Chinese and English
Effective time management skills
Well computer operation skills