Regulatory Affairs Specialist
BioMérieux SA
Beijing, 11,CN
13天前

Description

World leader in the field of in vitro diagnostics for over 50 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.

bioMérieux is present in over 150 countries through 43 subsidiaries and a large network of distributors. More than 90% of our sales are done internationally.

Its corporate headquarters are located in Marcy l’Etoile, near Lyon, in France.

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture.

We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit.

We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.

Our Group offers numerous possibilities : so come and join the 10,000 bioMérieux employees who have already identified with these values!

PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB :

Responsible for biomerieux import and local products registration within regular time frame. Contact with authorities (SFDA, SHFDA, NICPBP and so on) & hospitals in P.

R. China for each key milestone progress, including QC test, Clinical Trial, registration submission, CMDE Q&A, panel meeting, follow up and consultation.

Support RA head and manager on registration special cases as well as regulations watch-up.

MAIN ACCOUNTABILITIES :

  • 1.Establish registration plan and on time deliver each registration target according to RA annual plan, including new product, renew and product modifications;
  • 2.Study regulation in-depth and response related department’s questions to regulation;
  • 3.Contribute and organize regulation investigation when new changes occur at authority, and share with RA team members and related impacted department;
  • 4.Prepare registration submission files on time according to checklist, and actively communicate with corporate RA and other technical or project team for file buildup;
  • 5.On time deliver QC report according to project timeline and maintain good relationship with QC test centers;
  • 6.On time deliver clinical trial according to project timeline and maintain good relationship with CT;
  • 7.Well organize registration record and archive according to RA SOP and department procedures.

    Qualifications

    KNOWLEDGE, LANGUAGE AND EXPERIENCE :

    1.Master degree of biology or medical related major preferred

    2.1-3 years RA experiences in MD / IVD

    3.Good command of English in both written and oral

    4.Good interpersonal and communication skills

    5.Be able to work under pressure

    6.Responsiveness, respect of timeline and project management skill

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