Post-Market Surveillance (PMS) Manager (m/w/x)

Trust something new, grow beyond itself and redefine the boundaries of the feasible. That is exactly what our employees can and should live daily. To make a sign with our innovations and to enable great. Because there are a lot of fascinating people behind every successful company. In an open and modern environment with numerous development and further training opportunities, ZEISS employees work in a culture characterised by expert knowledge and team spirit. All this is supported by the special ownership structure and the long-term goal of the Carl-Zeiss Foundation: to advance science and society together. Today dare. Inspire tomorrow. Diversity is part of ZEISS. We look forward to your application regardless of gender, nationality, ethnic and social origin, religion, world view, disability, age as well as sexual orientation and identity. Apply in less than 10 minutes.

Seeing beyond - future of medical technology For more than 100 years, the medical technology of ZEISS has been driving progress in ophthalmology and microsurgery. In ophthalmology, our solutions help to maintain and improve the vision of people at any time of life. In microsurgery, our solutions enable targeted interventions on the diseased tissue, so that small and sensitive organs continue to function optimally ZEISS's medical technology supports medical professionals to improve the lives of patients worldwide. The fact that we have a direct influence on the welfare of the people with our actions is our daily drive

Your job You coordinate Post-Market Surveillance (PMS) activities and create the necessary documents for products and product families

They evaluate various data sources and create trend reports as part of post-market analyses and initiate necessary product improvements as a result of PMS data analyses

They support the development of the PMS process taking into account the further development of global standards and regulations

You create quality statistics and support in creating quality documents (SOPs, work instructions, forms)

They ensure the maintenance of the QM system according to ISO 13485:2016 and support internal and external audits

You create annual trending results for product risk management and work on appropriate analyses

You are responsible for area-specific meetings and plan and manage subprojects with

They support the validation and introduction of supportive PMS tools

Higher education preferably in a technical or scientific degree or equivalent professional experience in combination with a corresponding degree

Multiannual professional experience preferably in post-market surveillance, regulatory affairs or quality management in a medical device or pharmaceutical company

Professional knowledge of regulatory requirements (ISO 13485, EU MDR, MDSAP, requirements of relevant countries)

Basic knowledge of statistics Database analysis and analysis of regulatory requirements

An independent and sustainable way of working, combined with the ability to structure and analyze complex facts

Excellent communication skills and experience in cooperation in the intercultural environment

English language skills in word and writing and good knowledge of German language (B2)

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