Staff Global Regulatory GPO

Danaher Corporation•Chaska, MN

7d•Remote

About The Position

The Staff Global Regulatory Affairs ensures that Beckman Coulter products, processes, and documentation adhere to global premarket regulations for registration lifecycle management, global labeling requirements and marketing material review and approval procedures. This position reports to the Director of Global Compliance and Regulatory Affairs and is part of the Global Regulatory Affairs Department and will be fully remote. In this role, you will have the opportunity to develop, implement and execute global regulatory strategies to ensure worldwide compliance through standardized processes and procedures and support internal and external audits and regulatory inspections. You will also 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, and manage the regulatory requirements for the content of marketing, advertising, promotional, and sales product training and scientific material (MAPSS) and ensure global registration activities align with applicable regulatory requirements. Additionally, you will build strong partnerships with Business Unit Regulatory Affairs and Commercial Regulatory Affairs teams, sharing best practices and driving cross-functional initiatives.

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 and 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) and 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.