Senior Clinical Development Lead / Senior Medical Safety Physician (m/f/d)

Let’s build a healthier future, together. By combining unique strengths, Roche is redefining healthcare through sustainable action and innovation.

The mySugr GmbH was acquired by Roche in 2017 and the Vienna office is one of Roche's global sites. You will be located in the heart of Vienna, no matter if you work on a mySugr, Accu-Chek, navify or any other Roche product or solution.

Here's what we're looking for:

Serving as a Clinical Development Lead and Medical Safety Physician, your primary role is to uphold the safety and integrity of all Roche-branded products. You oversee the full product safety lifecycle, ranging from premarket risk evaluations to postmarket complaint resolution. Core responsibilities include delivering timely Medical Risk Assessments, Health Hazard Evaluations, Risk Enablers, and criteria for Potential Reportable or Safety Issues, alongside providing key clinical guidance for postmarket issues. Working collaboratively with experts across R&D, premarket and postmarket quality, Clinical Development, and vigilance, you act as the core medical authority and participate in Safety Board meetings.

As the Senior Clinical Development Lead / Senior Medical Safety Physician you are an independent, conscientious professional and a dedicated team player with a strong commitment to quality. You bring an interdisciplinary mindset, adaptability, and the confidence to make critical decisions. You build alignment across functions with differing priorities and inspire a positive and collaborative spirit.

Your upcoming mission:

• Conduct Risk Analyses: Create comprehensive medical risk analyses, Health Hazard Evaluations, Medical Risk/Safety Assessments, and Safety Board meetings to evaluate the clinical relevance of product complaints.
• Regulatory Communication: Process inquiries from international regulatory authorities related to adverse event reporting and product recalls.
• Expert Evaluations: Prepare internal and external medical safety evaluations and expert opinions for products across the Diagnostics portfolio, including Core Lab, Molecular Lab, Near Patient Care, and Diabetes Care.
• Process Optimization: Plan and conduct internal training sessions to optimize the operational interface between Customer Issue Resolution and Medical Safety.
• Safety Board Medical Leadership: Represent Medical Safety in the internal Safety Board process, providing the medical assessment that informs board decisions.
• Documentation Compliance: Maintain and regularly update procedural documents, guidelines, and SOPs/GSPs within your scope of responsibility.

Essential skills for your mission:

• Medical Education & Credentials: Degree in Human Medicine or equivalent; hands-on clinical experience is essential. A medical licence or equivalent registration is preferred.
• Clinical & Diagnostic Expertise: Initial clinical background combined with expertise in applied laboratory medicine and diagnostic methodologies is highly advantageous.
• Regulatory Standards: Familiarity with EU IVDR 2017/746 and US IVD regulations; experience with medical devices and medical device software is preferred.
• Risk Management Standards: Solid comprehension of key normative standards, including EN ISO 14971 and TR 24971.
• Interpersonal & Professional Skills: Strong collaborative ability, effective negotiation skills, analytical mindset, adaptability, and sound decision-making capabilities.
• Language Proficiency: Fluent in written and spoken English.

In Austria, Roche has a legal obligation to disclose the minimum salary according to the collective agreement, which is gross EUR 3.843 per month for this position. Roche offers competitive compensation packages which take current market trends into consideration, so candidates can expect a higher offer that reflects their experience level.

Who Roche is and what Roche cares about

Roche is committed to providing a healthy, equal and inclusive working environment for employees to bring true relief to the patient. Roche cares about family friendly career paths, sustainability, a healthy lifestyle and the flexibility of a modern workplace. The company maintains a culture of learning and sharing, as well as open and candid feedback. At every level, there are many opportunities to develop and grow, both professionally and personally.

As a healthcare pioneer committed to transforming the lives of people around the globe, Roche pushes boundaries to redefine what is possible. Roche works to improve standards of care through early, accurate diagnosis, targeted treatments, and sustainable, efficient healthcare built on people’s needs, strong data and clinical insights.

Interested? Click the Apply Now button and send your CV in English and anything else that might impress Roche.

Roche is an Equal Opportunity Employer.