regulatory affairs specialist

Posted 08 Apr 2019

Beijing - all, Beijing - China

Req Id 190208

Details

A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


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.

  •  

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)

What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
 

Curious? Apply and find more information at https://jobs.vibrantm.com
 

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