Global Regulatory Affairs Manager – IVD & Diagnostics

F. Hoffmann-La Roche AG; Northern (KY); Hybrid; USD 106,000 - 197,000; Full time

Job summary

Roche’s Global Regulatory Affairs team seeks a regulatory professional to support submissions across Laboratory Instruments, consumables and software, with a focus on Pathology and Digital Pathology. You will build dossiers, manage registration plans, and interact with external stakeholders to secure timely approvals.

Ideal candidates have 3–8 years in regulatory affairs in IVDs/medical devices, broad regulatory knowledge, and the ability to influence strategies across regions.

Qualifications

• 3–5 years experience in regulatory affairs (PhD: 3–5; Masters: 5–7; Bachelors: 6–8)
• Knowledge of USFDA, EU and international regulations is highly valued.
• Experience with Daily Management and Continuous Improvement practices.

Responsibilities

• Oversee regulatory document and submission compilation for complex products.
• Develop and manage parts of global regulatory submissions and registration plans.
• Interpret regulators' thinking to adapt strategies for different regions.
• Collaborate with cross-functional teams and external stakeholders to drive timely approvals.

Skills

Regulatory affairs knowledge

Stakeholder management

Project management

Cross-functional collaboration

Quality standards

Education

Bachelor’s degree in Life Science

Master’s degree in Life Science

Job description

Roche’s Global Regulatory Affairs team seeks a regulatory professional to support submissions across Laboratory Instruments, consumables and software, with a focus on Pathology and Digital Pathology. You will build dossiers, manage registration plans, and interact with external stakeholders to secure timely approvals.

Ideal candidates have 3–8 years in regulatory affairs in IVDs/medical devices, broad regulatory knowledge, and the ability to influence strategies across regions.