Global Regulatory Affairs Lead – Remote

Radiometer; United States; Remote; USD 140,000 - 170,000; Full time

Benefits offered by this job

Bonus eligibility

Benefits package

401(k) matching

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Senior Regulatory Affairs leader to shape global regulatory strategies and ensure worldwide compliance for products and marketing materials.

You will collaborate across Business Units and Commercial Regulatory Affairs, develop labeling requirements, and manage registrations while traveling to the US at least once a year.

Qualifications

• Bachelor’s degree in applicable fields with 9+ years of related work experience OR Master’s degree with 7+ years OR Doctoral degree with 4+ years.
• 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.
• Travel, Motor Vehicle Record & Physical/Environment Requirements: Ability to periodically travel to the US (minimum once a year).
• Prior experience with in vitro diagnostic devices or other regulated industries is a plus.

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.

Skills

Leadership

Cross-cultural collaboration

Regulatory knowledge

Written communication

Education

Bachelor’s degree in applicable fields with 9+ years

Master’s degree in applicable field with 7+ years

Doctoral degree in applicable field with 4+ years

Tools

Microsoft tools

Job description

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Senior Regulatory Affairs leader to shape global regulatory strategies and ensure worldwide compliance for products and marketing materials.

You will collaborate across Business Units and Commercial Regulatory Affairs, develop labeling requirements, and manage registrations while traveling to the US at least once a year.