Senior RA specialist_MD
Senior RA specialist_MD
Posted on :
24-08-2025
Employer Active
1 Vacancy
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Job Description
-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
oEnsure to obtain the regulatory permits on time in support of the organizations business requirements
oHaving 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
oEstablish working relationship with officials and experts in authorities good communication and negotiation with officials and experts to guarantee smooth registration
oSupporting Chinese IFU and Labeling projects copy reviews and other related projects
oProvide monthly report and analysis about latest registration status
oDevelop 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.
oBeing 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
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
oEnsure to obtain the regulatory permits on time in support of the organizations business requirements
oHaving 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
oEstablish working relationship with officials and experts in authorities good communication and negotiation with officials and experts to guarantee smooth registration
oSupporting Chinese IFU and Labeling projects copy reviews and other related projects
oProvide monthly report and analysis about latest registration status
oDevelop 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.
oBeing 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
Required Experience:
Senior IC
Employment Type
Full Time
Department / Functional Area
Key Skills
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