Danaher Corporation Sr Regulatory Affairs Analyst - Med Devices in Chaska, Minnesota
Danaher Company Description
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.
The Senior Regulatory Affairs Analyst will have re-market regulatory responsibility for immunoassay systems, instrumentation, software, reagents and automation products.
- Provide regulatory guidance and oversight to product development teams to ensure successful global product registrations
- Ensures timely preparation of organized and scientifically valid pre-market regulatory submissions for all geographies
- Engages in pre-market registration and compliance activities in accordance with Company procedures and regulatory requirements
- Creates, monitors and controls Regulatory project schedules related to pre-market activities
- Maintain global product regulatory compliance by reviewing design changes, labeling, advertising and promotional materials
- Coordination of on-going regulatory activities with Corporate Quality and Regulatory Affairs
- Communicating with domestic and international business partners and direct interaction with regulatory agencies on product issues and questions
- Exercises judgment within defined procedures and practices to determine appropriate action and influence teams and functions on requirements for maintaining compliance
- Develop and track project plans
- Monitors policies procedures and standards relating to Regulatory Affairs, evaluates impact and communicates to affected parties
- Recommends and leads changes to improve practices and procedures
- Provide international regulatory support through OUS product registrations and re-registrations as necessary
- Ability to teach, train, mentor, and enable others, and provide feedback to team members
- Additional product line support activities as directed by RA Manager
- Bachelor’s degree in sciences or technical field and 5 years of relevant experience, or a Master’s degree and 3 years of relevant experience, or Doctoral degree and 0-2 years of relevant experience
- Experience in Regulatory Affairs, Regulatory Compliance, or Quality Assurance specific to Medical Devices, In Vitro Diagnostics Devices, Pharmaceuticals or Biologics
- Experience in dealing with complex product issues and working across multiple functions and locations to meet requirements and goals
- Thorough knowledge of global regulatory requirements for in-vitro diagnostic products
- Ability to communicate clearly both verbally and in writing
- Excellent negotiation and diplomacy skills
- Experience in communicating with customers, suppliers, other departments, and senior management on complex issues
- Demonstrated highly analytical and ability to evaluate, analyze, and summarize large volumes of data and technical material efficiently
- Regulatory Affairs Certification (RAC) preferred
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.
Organization: Beckman Coulter - Diagnostics
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-MN-Chaska
Req ID: BEC011299