Staff Global Regulatory GPO

Danaher•Chaska, MN

7d•Remote

About The Position

At Beckman Coulter Diagnostics, a Danaher operating company, we are seeking a Staff Global Regulatory Affairs professional to ensure that our products, processes, and documentation adhere to global premarket regulations for registration lifecycle management, global labeling requirements, and marketing material review and approval procedures. This role is crucial for maintaining compliance and supporting our mission to innovate for tangible impact in life sciences, diagnostics, and biotechnology. You will thrive in a culture of belonging and continuous improvement, where your unique viewpoint matters and ideas are turned into impact at the speed of life. Beckman Coulter Diagnostics has been a global leader in clinical diagnostics for over 90 years, with diagnostic solutions used in hospitals, reference and research laboratories, and physician offices worldwide. Our systems process over one million tests every hour, impacting billions of patients and millions of clinicians annually. We enable clinicians to deliver the best possible care through improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

Requirements

Bachelor’s degree in applicable fields (such as biological sciences, biomedical engineering, or chemistry) with 9+ years of related work experience OR Master's degree in applicable field with 7+ years of related work experience OR Doctoral degree in applicable field with 4+ years of related work experience
Critically review global regulations and evaluate applicability and impact to BEC products and processes.
Develop clear written assessments and stakeholder-ready presentations to communicate regulatory requirements and recommendations.
Microsoft tool proficiency

Nice To Haves

Prior experience with in-vitro diagnostic devices or other regulated industries.
Leads effectively in matrixed and cross-cultural environments, driving timely decisions, issue resolution, and resource agility while setting high expectations and modeling accountability and integrity.
Communicates complex and sensitive information clearly across diverse audiences; builds consensus, demonstrates strong writing and documentation skills, and uses sound judgment to influence and lead through change.

Responsibilities

Develop, implement and execute global regulatory strategies to ensure worldwide compliance through standardized processes and procedures.
Support internal and external audits and regulatory inspections.
Manage, maintain and optimize tools and workflows used to manage the product regulatory lifecycle.
Develop and manage BEC global regulatory product labeling requirements and procedures.
Manage the regulatory requirements for the content of marketing, advertising, promotional, and sales product training and scientific material (MAPSS).
Ensure global registration activities align with applicable regulatory requirements.
Build strong partnerships with Business Unit Regulatory Affairs and Commercial Regulatory Affairs teams, sharing best practices and driving cross-functional initiatives.