Staff Labeling Specialist in Miami, Florida at Beckman Coulter Diagnostics

Date Posted: 9/16/2018

Job Snapshot

Job Description

Job ID: BEC011089

About Us

At Beckman Coulter, we are dedicated to advancing and optimizing the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We do challenging work on a global scale, and are invested in growing our associates’ careers. We embrace continuous improvement, and are passionate about moving science and healthcare forward.


We have a vital role at Beckman Coulter: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers all over the world.


Beckman Coulter is a Danaher company, operating in two industries: Diagnostics and Life Sciences. 


Description


The Regulatory Specialist will initiate, execute, report and close large scale Regulatory/Labeling projects.  The Regulatory Specialist will assist the Regulatory Program Manager with project planning, development, execution, reporting and interaction with project team, support regulatory labeling; new labeling and changes to existing labeling to ensure compliance with global requirements; review and approve labeling updates and provide regulatory support where needed.

Job Requirements



Qualifications

 Required Skills & Experience



  • Bachelor’s degree with 5+ years of experience, Master’s degree with 3+ years of experience, or Doctoral degree with 2+ years of experience in life sciences, engineering, or quality assurance

  • Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQE, CQA, RAC, Six Sigma, Lean Principles)


  • Experience in supporting regulatory labeling for new products and changes to labels for existing products in meeting global regulatory requirements.  Experience applying 21 CFR 801 and 820 regulations

  • Subject matter expertise in regulatory affairs for medical devices and in vitro diagnostics

  • Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and in vitro diagnostics

  • Experience in registration and commercialization of medical device and diagnostic products




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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 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.