长沙招聘

MAIN PURPOSE OF JOB

Responsiblefor regulatory affairs of Medical device (MD)/In vitro diagnostic (IVD),especially IVD antibodies, provide regulatory support to Merck Life sciencebusiness. Include but not limited, Work with global team and/or local agency toprepare regulatory submission documents for MD/IVD products, implement MD/IVDproducts registration/renew/supplementary application. Manage the registrationproject progress, make sure to meet the time line. Monitor MD/IVD relatedregulation changes, evaluate the impact, provide regulatory guidance in riskassessment and recommendations to mitigate potential risk. Work as effectiveinterface between company and authority/industry association.

Alsosupport on necessary work to ensure the efficient and timely registration of importedproducts to be launched in China by the Business Units with good maintenancebased on API/Excipient regulation in China.

MAIN JOB DUTIES/RESPONSIBILITIES

l Carryout all necessary work to ensure the efficient and timely application for MD/IVDproducts, including new registration/renewal/supplementary application etc.

l Serveas company’s representative for contacts with authorities such as NMPA, CMDEetc.

l Monitorand analysis any new published regulations, guidance regarding MD/IVD and do evaluation on the impact of companybusiness.

l Alsosupport on necessary work for API/Excipient registration with other teammembers.

EDUCATION AND LANGUAGE

l Majorin Biological, Microbiological, Pharmaceutical or related are required with bachelor’sdegree or above.

l FluentChinese native & English (verbal and written) is required

PROFESSIONAL SKILLS AND EXPERIENCE:

l Experience of minimum 1 years inregistration in MD/IVD Industry,

l Good regulatory knowledge of China lawsand regulations in MD/IVD. Familiar with US and European regulations ispreferred.

l Experiencein API&excipient registration area is preferred.

PERSONAL SKILLS AND COMPETENCIES:

l Goodcommunication with multi-departments

l Strongorganizational and time management skills.

l Good project management skills.

l Ability to manage multiple prioritiesand deliver accurate outcomes.

l Abilityto work in multi-cultural teams.

l Proficientin MS Office Software (word, Excel, PowerPoint etc)

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