Staff Global Regulatory GPO

The role involves ensuring global regulatory compliance for Beckman Coulter Diagnostics products, supporting registration, labeling, and marketing material review, and collaborating with cross-functional teams. It offers an opportunity to work remotely within a global leader in clinical diagnostics.

Location: Remote (US)

Salary: $140,000–$170,000/yr

Responsibilities

• Develop, implement and execute global regulatory strategies to ensure worldwide compliance.
• Manage, maintain and optimize tools and workflows used to manage the product regulatory lifecycle.
• Develop and manage global regulatory product labeling requirements and procedures.
• Manage regulatory requirements for marketing, advertising, promotional, and sales material, ensuring alignment with regulatory standards.
• Build strong partnerships with Business Unit Regulatory Affairs and Commercial Regulatory Affairs teams.

Requirements

• Bachelor’s degree in biological sciences, biomedical engineering, or chemistry with 9+ years of related experience, or Master’s degree with 7+ years, or Doctoral degree with 4+ years.
• Critically review global regulations and evaluate their impact on products and processes.
• Develop clear written assessments and stakeholder presentations.
• Proficiency in Microsoft tools.

Benefits

• Comprehensive benefit programs including health care, paid time off, and 401(k).
• Remote work flexibility.

Additional Information

• Position reports to the Director of Global Compliance and Regulatory Affairs.
• Annual salary range: $140,000 - $170,000.
• Eligible for bonus/incentive pay.
• Travel required: periodically to the US (minimum once a year).