10 days ago
Full-time
Mid Level
#healthcareinnovation#dialysiscare#sustainablehealth
Risk Manager*in (m/f/d)
Risk Manager (m/w/d) Medical Devices
Your responsibilities:
- Identification, analysis, evaluation, and documentation of product and process-relevant risks for medical devices acc. to ISO 14971 and other applicable regulations
- Evaluating the safety relevance of hazards or hazardous situations in collaboration with technical experts
- Supporting the project teams in the technical development and implementation of risk control measures and analyzing their effectiveness
- Supporting the identification, investigation, and GAP Analysis of regulatory requirements for medical devices
- Supporting the creation, review, and update of technical documentation
- Supporting the creation of market access & registration strategies for active and non-active medical devices as well as SaMD
- Supporting the creation, review and update of Quality Management System Documentation incl. all relevant documentation
- Supporting the regular screening of worldwide regulatory requirements
Your profile:
- Solid academic foundation in fields such as medical technology, engineering, computer science, or physics, or equivalent expertise through a comparable qualification.
- Ideally 2-5 years of professional experience in risk management, quality management and regulatory affairs of medical devices
- Good technical understanding of systems with mechanics, software, and hardware.
- Good Knowledge of MDR, ISO 14971, ISO 13485, IEC 62304 and safety analysis (FMEA, FTA)
- Excellent communication and team player skills
- Independent and results-oriented way of working
- Good analytical and decision-making skills
- Fluency in German and English (written and spoken) – another language is a plus
What we offer:
- A diversified and challenging environment combined with a high degree of freedom for the implementation of innovative ideas
- A permanent employment contract with performance-related pay at an international and promising employer
- A modern workplace in spacious and bright offices in the heart of Hamburg with a view of the River Elbe
- A supportive working atmosphere in a dynamic team with short decision paths
- An individually tailored “on the job” training and professional development opportunities
- Personal added values such as a company pension scheme, team events, employee discounts, bike leasing and much more
Do you see this job offer as a personal challenge and do you want to make a difference? Then share your application, including your salary expectations and your earliest possible starting date, with us by clicking on “Apply for job”.
We are looking forward to meeting you!
10 days ago
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