Regulatory Affaris Supervisor_Beijing in Beijing, China at Beckman Coulter Diagnostics

Date Posted: 7/6/2019

Job Snapshot

Job Description

Job ID: BEC014499

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

BASIC PURPOSE OF THIS POSITION:

Manage responsible product line to get product registered timely in NMPA to align with business need.  To contact relative departments and manufacture to gain necessary files of products, to compile product standard for key product and coordinate in type-test and complete entire registration process.  Solve the difficulties in the registration process through extended ideas such as workshop and onsite training program.  Participate in the process to optimize and lead the team (if applicable) to execute the changes.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

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


  • • Make RA strategy for each product line to make sure to get NMPA certificates in a reasonable timeline
  • • Manage team members’ daily work and control the budget (if applicable)
  • • Responsible for key registration projects
  • • Clearly communicate with manufacturer about NMPA requirements and provide the format of key documents
  • • Good relationship and interact with government agency, and internal departments in company
  • • Communicate proactively with industry associations, standards agencies and regulatory organizations
  • • Use DBS tools to improve the current work
  • • Review promotion materials (if applicable)
  • • Measure KPI for team members (if applicable)
  • • Arrange team to support recall, stop-shipment, biding, advertisement, production license in Suzhou Site (if applicable) 


This description is a summary of principle responsibilities and is not intended to include all duties may be assigned.


WORKING RELATIONSHIPS AND CONTACTS:

  • • External contacts for this position include NMPA, type-test center and industry standard committees and industry associations 
  • • Internal contacts include headquarter, marketing team, logistic team, application and sales/ service team etc. to gain support from them to resolve problem and make project forwarding. 


SUPERVISION RECEIVED AND GIVEN:

The incumbent of this position is responsible for the team’s work (if have direct reports).  Half of the work may require analysis and use of initiative and independent judgment, but most assignments are specific and well defined. 


Job Requirements



Qualifications

ESSENTIAL QUALIFICATIONS:

EDUCATION & SKILLS:

  • Bachelor degree or above of clinical, laboratory medicine, medical engineering, chemistry, biology and pharmaceutical or above is preferred.
  • Excellent English skills in listening, speaking, reading and writing


WORKING EXPERIENCE:

  • More than four years’ experience on similar position in IVD industry


FUNCTIONAL COMPETENCIES:

This position also requires:

  • Be experienced in regulatory and/or clinical field, be familiar with NMPA and international or national regulation of medical devices and/or IVD
  • Excellent team work and interpersonal communication skill 
  • Positive & take responsibility
  • Analysis & Judgment, overcomes potential stumbling blocks to achieve objectives
  • Resolves issues and conflicts using effective negotiation, persuasion skills and management tools.


TRAVEL REQUIREMENTS: 

This position may require business traveling in an ordinary situation.



WORK ENVIRONMENT:  

This position functions in a general office environment.  




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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