About this role
About the Role Beckman Coulter Diagnostics, a Danaher operating company, seeks a Staff Global Regulatory Affairs professional to develop and execute global regulatory strategies, manage product labeling, and ensure compliance across the global lifecycle. This remote role reports to the Director of Global Compliance and Regulatory Affairs as part of the Global Regulatory Affairs Department. What You'll Do
- 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. What We're Looking For
- 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
- Travel availability Nice to Have
- Prior experience with in-vitro diagnostic devices or other regulated industries.
- Ability to lead effectively in matrixed and cross-cultural environments, driving timely decisions and resource agility while setting high expectations and modeling accountability and integrity.
- Strong written and verbal communication with diverse audiences; ability to influence and lead through change. Compensation & Benefits
- Salary: $140,000 - $170,000 per year
- Bonus/incentive pay eligibility
- Comprehensive benefits including paid time off, medical/dental/vision insurance and 401(k)
- Flexible/remote work arrangement possible; on-site option may be available depending on role and location