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regulatory affairs specialist

MAIN PURPOSE OF JOB

 

Responsible for regulatory affairs of Medical device (MD)/In vitro diagnostic (IVD), especially IVD antibodies, provide regulatory support to Merck Life science business. Include but not limited, Work with global team and/or local agency to prepare regulatory submission documents for MD/IVD products, implement MD/IVD products registration/renew/supplementary application. Manage the registration project progress, make sure to meet the time line. Monitor MD/IVD related regulation changes, evaluate the impact, provide regulatory guidance in risk assessment and recommendations to mitigate potential risk. Work as effective interface between company and authority/industry association.

 

Coordinate documents preparation for import permit application, submit and follow up application process with local authority, make sure get import permit approval per plan. For example, apply for related import permits, e.g. pesticide reference material Import Permit etc.;

 

 

MAIN JOB DUTIES/RESPONSIBILITIES

  • Carry out all necessary work to ensure the efficient and timely application for MD/IVD products, including new registration/renewal/supplementary application etc.
  • Serve as company’s representative for contacts with authorities such as NMPA, CMDE etc.
  • Monitor and analysis any new published regulations, guidance regarding MD/IVD and do evaluation on the impact of company business.

    Submit documents for pesticide reference material import permit application, submit and follow up application process with local authority, make sure get import permit approval per plan.

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EDUCATION AND LANGUAGE

  • Major in Biological, Microbiological, Pharmaceutical or related are required with bachelor’s degree or above.
  • Fluent Chinese native & English (verbal and written) is required

 

 

 

 

PROFESSIONAL SKILLS AND EXPERIENCE:

  • Experience of minimum 1 years in registration in MD/IVD Industry.
  • Good regulatory knowledge of China laws and regulations in MD/IVD. Familiar with US and European regulations is preferred.
  • Bachelor’s degree with biological science related background.
  • Experience in API&excipient registration area is preferred.  
  • Fresh graduates with intern experience on above area or other strong capability showed will be considered.

PERSONAL SKILLS AND COMPETENCIES:

  • Good communication with multi-departments
  • Strong organizational and time management skills.
  • Good project management skills.
  • Ability to manage multiple priorities and deliver accurate outcomes.
  • Ability to work in multi-cultural teams.
  • Proficient in MS Office Software (word, Excel, PowerPoint etc)
Job Requisition ID:  190208
Location:  Beijing - all
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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