Senior Clinical Development Lead Senior Medical Safety Physician (mfd)

Lets build a healthier future together! By combining our unique strengths we are redefining healthcare through sustainable action and innovation. For a behind-the-scenes look check out this video to see how we at Roche are making personalized health care a reality.

The mySugr GmbH was acquired by Roche in 2017 and our Vienna office is one of Roches global sites. You will be located here in the heart of Vienna no matter if you work on a mySugr Accu-Chek navify or any other Roche product or solution. You can read more about the history of mySugr & Roche here.

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 (Core Lab Molecular Lab Near Patient Care Diabetes Care).

• Process Optimization: Plan and conduct internal training sessions to optimize the operational interface between Customer Issue Resolution (CIR) 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 all procedural documents guidelines and SOPs/GSPs within your scope of responsibility.

• Medical Education & Credentials: Degree in Human Medicine (MD 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 (EU MDR 2017/745).

• 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 we have a legal obligation to disclose the minimum salary according to our collective agreement which is gross EUR 3.843 - per month for this position. But! Rest assured we offer amazing competitive compensation packages which take into consideration current market trends therefore you can expect a higher offer that reflects your experience level.

Who we are and what we care about

We are committed to providing a healthy equal and inclusive working environment for our employees to bring true relief to the patient! We care about family friendly career paths sustainability a healthy lifestyle and the flexibility of a modern workplace. We maintain 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 billions of people around the globe we push boundaries to redefine what is possible. We know that early accurate diagnosis is essential to maintain health prevent disease and help advance new targeted treatments and potential cures for the worlds most serious health problems. We have a passion for innovation and a profound commitment to make a lasting impact on society by continuing to improve the standard of care for humankind. Our culture inspires us to create healthcare that is sustainable efficient and financially viable. Healthcare that is built on peoples needs strong data and clinical insights. Healthcare that saves lives.

Interested Great. Wed like to hear from you! Just click that Apply Now button and send us your CV in English . and anything else that you think might impress us.

Roche is an Equal Opportunity Employer.