Associate Director Regulatory Affairs in Nationwide China at Beckman Coulter Diagnostics

Date Posted: 9/4/2019

Job Snapshot

Job Description

Job ID: BEC015877

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:

  • Actively recruit, develop and retain talent within the China Commercial Q&RA organization

•         Establish and drive successful fulfillment of China Commercial RA objectives; monitor and report on progress to these objectives

•         Ensure timely and compliant registration of products in accordance with China commercial and product business unit objectives

•         Support the establishment and fulfillment of China Commercial Operations objectives

•         Set and monitor performance to the China Commercial RA budget

•         Ensure a close and effective relationship with the NMPA and provincial FDA and other regulatory agencies as required.

•          Liaise with the global Q&RA organization to support the development of and ensure alignment with BEC global policies and procedures

•         Provide detailed and up to date regulatory intelligence for China through maintenance of an external advocacy network and other data sources as appropriate

•          Support the application of DBS tools throughout China and drive DBS activity within the China RA team

  • Ensures staff skills are developed and maintained on a continual basis to ensure

cost/effective operations

  • Maintaining the RA related procedures and monitoring the execution of RA team.

Job Requirements



Qualifications

ESSENTIAL QUALIFICATIONS:

EDUCATION & SKILLS:

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

•         Be familiar with ISO13485: 2003, and the certified internal auditor for the quality management system 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.

•         Fluent in written and spoken English skills

 

 

WORKING EXPERIENCE:

•         More than seven years’ experience on RA management.

 

 

FUNCTIONAL COMPETENCIES:

This position also requires:

•          Skilled at managing ambiguity, influencing without authority and driving for results

•         Experience of working within a global, multi-cultural, matrix organization

•          Deep and current knowledge of China IVD and related regulations

•          Solid working knowledge of Lean Six Sigma principles

•          Proven success in building and leading a team and developing talent 



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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.