RA Manager-MB_Beijing in Nationwide China at Beckman Coulter Diagnostics

Date Posted: 8/6/2019

Job Snapshot

Job Description

Job ID: BEC015642

About Us

Founded in America by Professor Beckman and the Coulter brothers, Beckman Coulter Limited is dedicated to the to the development and sale of instruments, reagents, software and products that simplify and automate laboratory processing that are widely used in hospitals, clinics, and commercial laboratories worldwide. Clinical diagnostic tools implemented within company products include: laboratory automation systems, biochemical analytical systems, immunoassay systems, hematology systems, protein chemistry systems, urinalysis systems, microbiological detection and analysis systems, and blood bank analytical systems. In future developments, Beckman Coulter will continue to lead in the field of medical equipment research and development with cutting-edge technology and complete product lines, and continue to make outstanding contributions to the development of global scientific research! For more information, please visit www.beckmancoulter.com.


Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The incumbent will also be responsible for, but not limiting to the following duties:

  • Task with meeting monthly, quarterly and annual objectives and provide direction for the responsible regulatory team to attain them
  • Make the registration strategy, project planning and the implementation, to get CFDA and other required certificates in a reasonable timeline
  • Contact relative departments and manufacture to gain necessary support and alignment
  • Be responsible for hiring/firing/disciplinary decisions affecting employees
  • Ensure staff skills are developed and maintained on a continual basis to ensure

cost/effective operations

  • Good interface with NMPA, CMDE, test center and other agencies to well understand regulation, guidelines and standards requirements.
  • Clearly communicate with manufacture, marketing, as well as cross functional team
  • Maintaining the RA related procedures and monitoring the execution of RA team.
  • Control the budget and actual cost of responsible RA team
  • Adheres to policies and procedures

Job Requirements



Qualifications

ESSENTIAL QUALIFICATIONS:

EDUCATION & SKILLS:

•         Bachelor degree of laboratory medicine, medical engineering, and pharmaceutical or above is preferred.

•         Must possess excellent communication (both written and verbal), influential and negotiating skills, assuring effective communication of complex regulatory information to a wide variety of audiences.

•         Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.

•         Excellent team work and interpersonal communication skill

•         Fluent in written and spoken English skills

 

 

WORKING EXPERIENCE:

•         More than five years’ experience on similar position in this area.

 

 

FUNCTIONAL COMPETENCIES:

This position also requires:

•         Be experienced in regulatory field, be familiar with NMPA and international regulation of medical devices and/or IVD

•         Good attitude, well habit of work, positive & take responsibility

•         Analysis & Judgment

•         Customer service oriented

•         Possess demonstrable leadership skills; has the ability to move others to action, including peers, superiors and subordinates. Demonstrate a positive, results-oriented style.   Able to develop others, and manage performance of team through coaching and feedback, willing/able to share personal knowledge and experience with others.

•         Not afraid to stand up for his/her beliefs or voice an unpopular opinion. Is looked at for direction in a crisis. Willing to try new ways without fear of failure.   Takes stands to resolve important issues.  Energized by tough challenges. Is comfortable with change.

•         Able to foster good relationships with cross functional team. An ability to create a partnership atmosphere with internal and external resources while achieving key operating objectives. Can see and understand what drives policies, practices, and procedures. 

•         A confident individual who provides a good balance of risk taking and sound judgment in order to deliver optimal results. Is able to drive goal attainment in others with energy and focus.



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
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