Senior Regulatory Affairs Analyst – In Vitro Diagnostics in Brea, California at Beckman Coulter Diagnostics

Date Posted: 4/3/2018

Job Snapshot

Job Description

Job ID: BEC010158

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

Regulatory Affairs associates interpret federal/state/international regulations as they apply to Beckman Coulter products, processes and/or procedures, advises on impact of regulations, and devises strategies to compliance. They may liaise with external regulatory, government, or other associated agencies. Secures necessary country licenses (country approvals), certificates (e.g. CFGs, COE), and renewals (e.g. CE renewals) required to market products in that geography. Ensures company complies with the local regulatory requirements of the country in which the product is marketed. Prepares the necessary documentation, secures necessary approvals, and executes on product recalls. Respond to regulatory agency inquiries.



In this role, the successful applicant will work with interdisciplinary teams to support the development activities for Beckman Coulter devices, manufacturing processes, and post market assessments to ensure compliance with local and international regulations, directives, and standards.



Responsibilities



  • Must be a strong collaborative facilitator and leader, building consensus while championing global regulatory compliance

  • Ensure business teams consider, document, and provide data-driven rational to support the impact of changes to materials, product and process changes; ensuring company practices are consistent with the corporate regulatory risk posture

  • Ensure post-market product regulatory compliance, demonstrated by timely, consistent review and presentation of product / process changes to the company’s premarket council, minimizing the risk of regulatory actions that could impact our business

  • Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively

  • Utilize Danaher Business System (DBS) tools to drive compliance and effective processes; developing regulatory metrics and scorecards and institute data-based process improvements which will align with corporate and business unit goals

  • Assure that there are no significant interruptions to the business due to compliance issues

Job Requirements



Qualifications

Required Skills & Experience



  • A 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)

  • Comprehensive understanding of manufacturing processes, chemistry and engineering principles

  • 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

  • Possess a broad knowledge of surrounding areas including Quality Assurance, Manufacturing and Development.

  • Demonstrated track record of developing organizational understanding and capability as it applies to regulatory affairs.

  • Global experience leading and/or participating on cross functional teams


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 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% 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.