Remote Senior Regulatory Affairs Leader – IVD Diagnostics

Danaher Corporation; Miami (FL); A distancia; USD 116.000 - 150.000; Jornada completa

Descripción de la vacante

Beckman Coulter Diagnostics, a Danaher operating company, is seeking a Staff Regulatory Affairs professional to shape regulatory strategies for IVD products. You will partner with senior leadership across functions to advance registrations, labeling, and lifecycle management while ensuring global market access.

The role is fully remote with up to 10% travel, supporting the United States, Europe, and other global markets.

Formación

• 8+ years regulatory affairs experience with medical devices or IVDs.
• Expertise in US FDA and EU IVDR requirements including lifecycle management and registrations.
• Ability to assess verification/validation data, study designs and regulatory impact.
• Ability to influence cross-functional stakeholders on submissions and changes.
• Willingness to travel up to 10%, domestically and internationally.

Responsabilidades

• Develop and execute regulatory strategies for US, EU, and global markets.
• Assess complex data and study designs to inform decisions.
• Collaborate across functions to implement compliant product changes.
• Lead regulatory activities for high-impact projects and submissions.
• Mentor colleagues and drive continuous regulatory improvements.

Conocimientos

Regulatory strategy

FDA & EU IVDR

Data evaluation

Cross-functional leadership

Travel readiness

Educación

Bachelor's degree in Regulatory Affairs or related field

Descripción del empleo

Beckman Coulter Diagnostics, a Danaher operating company, is seeking a Staff Regulatory Affairs professional to shape regulatory strategies for IVD products. You will partner with senior leadership across functions to advance registrations, labeling, and lifecycle management while ensuring global market access.

The role is fully remote with up to 10% travel, supporting the United States, Europe, and other global markets.