Remote Global Regulatory Affairs Specialist

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

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, is seeking a senior regulatory affairs professional to drive global regulatory strategies and ensure worldwide compliance across product labeling and MAPSS content.

The role supports internal and external audits, partners with BU Regulatory Affairs, and enables cross-functional initiatives. Remote work is eligible, with a base in the US region.

Qualifications

• 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

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

Regulatory strategy

Global compliance

Audits & inspections

Education

Bachelor’s degree in biological sciences/biomedical engineering/chemistry

Master’s degree in applicable field

Doctoral degree in applicable field

Tools

Microsoft Office

Job description

Beckman Coulter Diagnostics, a Danaher operating company, is seeking a senior regulatory affairs professional to drive global regulatory strategies and ensure worldwide compliance across product labeling and MAPSS content.

The role supports internal and external audits, partners with BU Regulatory Affairs, and enables cross-functional initiatives. Remote work is eligible, with a base in the US region.