Risk Manager Medical Technology | Risk Manager Medical Devices (m/f/d)

Would you like to accompany sophisticated medical technology projects, advise customers at eye level and take responsibility for innovative medical devices? For our client we are looking for an experienced Risk Manager (m/w/d) in full time, unlimited.

Our client is an established medical technology consulting company and supports international manufacturers in the development, admission and market launch of innovative medical devices. It expects a modern working environment with flat hierarchies, short decision-making paths and large design playroom. The company combines the flexibility and dynamics of specialized consulting with the stability of a successful group in the background.

In this position, you advise customers on all issues of risk management and accompany medical devices across the entire product development and product life cycle – from the concept phase to market surveillance. No pure standard expert is sought, but a personality that has already applied the methods of risk management according to ISO 14971 itself, has created risk analyses and has accompanied technical project teams in the development of safe medical devices. A thorough understanding of active medical devices is of particular importance.

Individually responsible advice from customers in risk management for medical devices according to ISO 14971 as well as medical devices over the entire product development and product life cycle Implementation of risk and risk analyses and evaluation of product-related risks Development, implementation and evaluation of appropriate risk control measures together with interdisciplinary project teams Analysis of regulatory requirements, implementation of CAP analyses and ensuring compliance Preparation, testing and maintenance of technical documentation according to MDR and relevant standards Development of approval and market access strategies for active and non-active medical devices and software as a Medical Device (SaMD)

Successfully completed studies in medical technology, engineering, physics or a comparable discipline Multiannual professional experience in risk management, product development, quality management or regulatory affairs for medical devices Practical experience in the independent implementation of risk management according to ISO 14971, including risk analyses, risk assessments and risk control measures Understanding complex systems of mechanics, software and hardware, ideally in the field of active medical devices expertise in relevant regulations and standards, in particular MDR, ISO 14971, ISO 13485, IEC 62304 and safety analysis methods such as FMEA and FTA Structured, analytical and self-responsive operation as well as safe occurrence in customer contact Very good knowledge of English; German knowledge is advantageous

Attractive, performance-oriented remuneration and an indefinite contract 30 days holiday as well as an attractive home office share Exciting consulting projects at leading companies in medical technology Flat hierarchies, short decision paths and a lot of design space The dynamics of a specialised consulting company combined with the security of an international group Modern workplace in an attractive location in the city centre of Hamburg with views of the Elbe Individual training and development opportunities Attractive additional services such as occupational retirement, team events, employee discounts, bike leasing and much more Individually tailored incorporation (“on-the-job training”) as well as diverse possibilities for professional and personal development Collaborative corporate culture with open communication and appreciation