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Clinical Affairs Manager (f/m/x) for AI related Digital Medical Devices

München
Vollzeit
21.01.2023

Your Role: As Clinical Affairs Manager (m/f/x) you will work in a team on the creation and implementation of the clinical strategy for the international approval of new and further developments of medical devices with focus on SaMD. For this purpose you define, plan and implement necessary clinical projects and evaluate clinical data for product definition, regulatory and marketing purposes. For the optimal design of medical device development you will work in close coordination with Regulatory Affairs, Development, Quality Management, Product Management and global Clinical Affairs Teams. You can expect the following tasks: Coordinate with your team colleagues to plan and prepare clinical assessments according to MDR, MEDDEV 2.7/1 revision 4 Support in the definition and implementation of clinical strategies for international approvals outside the EU (e.g. China, USA) Independent planning and fulfillment of activities on medical devices in the area of Post Market Clinical Follow-Up and support in the area of Post Market Surveillance Support of product management in the definition of intended use, clinical claims and release of marketing materials, taking into account the available clinical evidence Planning and execution of clinical studies worldwide in compliance with applicable laws, regulations and Good Clinical Practice Support of Investigator Initiated Trials Support of the project manager of development projects in the coordination of interfaces of all clinical tasks assigned to the project with regard to content, execution, scheduling and technical documentation Generate clinical evidence using bench tests, validations, etc. Performing and evaluating literature searches Creation of harmonized Standard Operation Procedures and Work Instructions after performing gap analyses taking into account regulatory requirements Your profile: a university degree in medicine, medical technology, ophthalmic optics/optometry or natural sciences (alternatively state-approved optometrist or comparable training) Ideally 3 years relevant professional experience in the field of clinical affairs or clinical research in the medical technology industry, ideally SaMD Profound knowledge of the relevant regulatory requirements for clinical evaluations and clinical studies for medical devices, ideally SaMD Practical experience in project management Practical experience in medical writing Global understanding of the requirements for the approval of medical products Interest in digital software products and advanced technologies concepts such as Artificial Intelligence, Machine Learning, Cloudbased Products and more Analytical skills and creativity as well as strong communication and organizational skills in an international environment A high level of commitment and creative drive as well as strong communication skills and organizational talent in an international environment the ability to communicate confidently in English, ideally also in German Your ZEISS Recruiting Team: Dogan Küncekli Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together. Join us today. Inspire people tomorrow. Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity. Apply now! It takes less than 10 minutes.

Clinical Affairs Manager (f/m/x) for AI related Digital Medical Devices

Premium company ZEISS Gruppe
München
Vollzeit
Fachkraft/Berufserfahrene

Veröffentlicht am 21.01.2023


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