Regulatory Affaris Specialist_Beijing in Beijing, China at Beckman Coulter Diagnostics

Date Posted: 7/9/2019

Job Snapshot

Job Description

Job ID: BEC014218

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

� Well schedule the registration projects, to make sure to get SFDA certificates in a reasonable timeline � Collect the useful technical documents to compile product standard, coordinate on product test and cooperate with relevant technical department � Clearly communicate with manufacturer to gain the needed documentations and match SFDA requirements � Good interface with government agency, and internal departments in company � Communicate industry lobbies, standards agencies and regulatory organizations � Perform internal post-marketing surveillance policy and report, follow up with SFDA

Job Requirements



Qualifications

More than three years experience on similar position in this area with Bachelor degree of medical test, laboratory medicine, medical engineering, and pharmaceutical or above is preferred. This position also requires: � Be experienced in regulatory and/or clinical field, be familiar with SFDA and international 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 and persuasion skills � Excellent English skills in speaking, reading and writing



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.