Staff Global Regulatory GPO

About the role

The Staff Global Regulatory Affairs position at Beckman Coulter Diagnostics is a critical role within the company's regulatory framework. This position reports to the Director of Global Compliance and Regulatory Affairs and is part of the Global Regulatory Affairs Department.

Responsibilities

• Develop, implement, and execute global regulatory strategies to ensure worldwide compliance through standardized processes and procedures.
• 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.

Requirements

• Bachelor’s degree in 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.

Essential Requirements

• Ability to periodically travel to the US (minimum once a year).
• Prior experience with in-vitro diagnostic devices or other regulated industries.
• Leadership skills, including leading effectively in matrixed and cross-cultural environments, driving timely decisions, issue resolution, and resource agility while setting high expectations and modeling accountability and integrity.
• Strong communication and documentation skills, able to convey complex and sensitive information clearly across diverse audiences.