Danaher Jobs

Description:

The RA specialist provides subject matter expertise and works with a team of regulatory affairs professionals to ensure that Beckman Coulter establishes best practices within the assigned area of responsibility (Product & site registration, Design change re-registration, PMS registration, Promotional material review, Regulatory advocacy, and, etc.).

Key responsibilities include:

Lead the preparation of premarket submission documents & smart registration strategy; Lead the tactical product registration of Immunoassay, Clinical chemistry, Hematology, Microbiology, etc. by communicating directly with a global RAs, regulatory agencies, and so on. Maintain KGMP certificate new/renewal by cooperating with global manufacturer QRAs & R&D for business continuity. Work closely with country/BU regulatory, marketing, CAS, SVC and other professionals across the company to develop & implement company-wide programs and processes for QARA compliance within areas of responsibility. Identify regulatory trends and their implications for Beckman Coulter; Develop & implement effective regulatory strategies to meet business objectives; Scan the external environment and work with external associations to proactively adapt regulatory strategies and influence change within areas of responsibility, and to communicate with global RI channel to deliver the change of regulatory environment to input the design change process. Educate, train, & advise company professionals to ensure compliance with RA requirements. Audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety. Develop QRA performance KPI metrics to identify program weaknesses & drive improvements in procedures or oversight.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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