Johnson & Johnson Careers
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Requisition ID: 1805651659W
Principal Duties and Responsibilities
Ø Product registration related including new, change and extension:
· Handling registration process, including
- document requirement
- sample ordering, type testing
- dossier prepare
- submit to SDA
- follow up SDA evaluation procedure
- solve various problems in whole process
- file dossiers with consistent requirement
· Ensure to obtain the regulatory permits on time, in support of the organization's business requirements
· Having a good and consistent communication with local marketing and known well the business plan especially product launch plan
· Establish working relationship with officials and experts in authorities, good communication and negotiation with officials and experts to guarantee smooth registration
· Paying attention to the market information such as the competitors’ with the analysis
Ø To coordinate the post market surveillance project
Ø Supporting Chinese IFU /labeling, copy review for product related
Ø Maintain & Input database like: RA database, RTL…
Ø Providing monthly report & analysis including latest registration status & post market surveillance
Ø 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.
- Medical or related education background and knowledge
- 1-3 years Medical Device registration experience
- Good communication skill
- Better English and Chinese in writing and oral
- Well computer operating
- Good time management
Johnson & Johnson Medical Shanghai Ltd. (7055)