Vienna Clinical Development Lead - Diabetes SaMD

Roche; Wien; On-site; EUR 120,000 - 170,000; Full time

Job summary

Roche Vienna seeks a Clinical Development Lead with specialized diabetology expertise to provide strategic medical leadership across product design, regulatory clearance, and lifecycle management for the Roche Diabetes portfolio. You will guide CGM sensors, predictive algorithms, and SaMD development, shaping clinical claims and regulatory submissions.

The role requires crafting clinical evaluations, managing medical inputs, and collaborating with R&D, regulatory, and clinical teams to ensure

Qualifications

• Medical degree (MD) or relevant PhD; clinical training in endocrinology/diabetology preferred.
• Experience in medical device or SaMD design controls and clinical evaluation documentation.
• Strong English writing and communication; capable of interfacing with global health authorities.

Responsibilities

• Define intended use, indications, and clinical claims for Roche diabetes devices.
• Lead clinical evaluation plans and reports under EU MDR and FDA pathways.
• Provide medical input into design reviews, safety, and risk management.
• Collaborate with R&D, product management, and regulatory teams across the development lifecycle.

Skills

Clinical leadership

MD/PhD

Diabetes expertise

Regulatory knowledge

Medical writing

Fluent English

SaMD development

Regulatory strategies

Education

MD or equivalent

PhD in a related field

Job description

Roche Vienna seeks a Clinical Development Lead with specialized diabetology expertise to provide strategic medical leadership across product design, regulatory clearance, and lifecycle management for the Roche Diabetes portfolio. You will guide CGM sensors, predictive algorithms, and SaMD development, shaping clinical claims and regulatory submissions.

The role requires crafting clinical evaluations, managing medical inputs, and collaborating with R&D, regulatory, and clinical teams to ensure