Risk and Validation Manager Medical Devices - Largely Home Office

Project overview

Our client, a medical technology research company, is looking for support from a Risk and Validation Manager (m/f/d) with a background in medical technology, effective immediately. The role can be largely remote - there will also be occasional on-site appointments in Munich.

Skills

• Determination and definition of clinical requirements for new product and function developments as well as support for the transfer into new projects within the scope of clinical trials and evaluations.
• Collaboration with field service and medical specialists to define benchmarks for evaluating the clinical performance of these products and functions.
• Simulation and testing of selected project aspects for the evaluation of prototypes and validation of results with regard to the intended use; analysis of field data and results from research studies.
• Creation and management of preclinical evaluation protocols, data analyses, and reports.
• Participation in the evaluation and validation of specific systems or projects for conducting feasibility studies, usability and human factors analyses, technology assessments, concept, benchmarking, and approval studies.
• Support for the risk management file and clinical evaluation reports to support the product throughout its entire lifecycle.
• Compliance with the requirements of the US FDA, other regulatory requirements, company guidelines, standard operating procedures (SOPs), internal processes, and work orders; maintenance of constructive, cooperative communication and collaboration with employees at all levels, customers, service providers, and suppliers.
• Degree in Medical Technology, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Biology, Physics, or equivalent.
• Several years of experience in medical technology product development and in the area of Risk/Validation Management.
• Proven ability to apply understanding of clinical applications to problems to lead tasks within assigned projects to a solution.
• Proven ability to effectively integrate information from various disciplines, including Clinical Affairs, Engineering, Marketing, and Regulatory Affairs.

Project details

• Start: 16.11.2026
• Duration: unbefristet
• Location: 80469 München, DE
• Languages: German