Risk Manager Medical Devices
Location
Minden, Kreis Minden Lübbecke | Germany
Job description
Are you passionate about advancing healthcare through innovation and technology? Klavant GmbH, located in Minden, is seeking a dedicated Risk Manager with medical engineering background to join our team.
At Klavant, we are committed to revolutionizing cardio-vascular patient treatment with cutting-edge Class III devices and software solutions. We foster a culture of collaboration, creativity, and a deep-seated commitment to harnessing the latest technology to transform the healthcare landscape. Our diverse team, consisting of software developers, engineers, and healthcare professionals, excels in creating state-of-the-art medical devices and software.
Your responsibilities
- Communication with notified body, competent authority
- Reliable handling of current standards (MDR 2017/745, ISO 14971)
- Perform risk assessment by analyzing current risks and identifying potential risks
- Collaborate with internal and external auditors in conducting policy and compliance audits
- Provide support and training to staff to build risk awareness amongst your team members
- Maintain records of insurance policies and claims
- Negotiate all modifications to Quality Assurance Agreement
Your profile
- Completed scientific or technical studies
- Several years of experience in the development of medical devices, ideally coupled with practical medical experience for class III devices and common knowledge of medical device standards (e.g. ISO 13485, ISO 14971, IEC 62304)
- Good technical understanding of systems, and experience in the areas of risk management and safety analyses (FMEA, FTA, PHA)
- Analytical, systematic way of working, strong communication skills and willingness to take responsibility
- Clear communication internally as well as to external partners, customers and notified bodies
- Confident German and English (spoken/written)
We offer
- A job with bright opportunities: at our company, everything revolves around the development and safety of medical devices for both patients and users
- Embrace teamwork: Open communication, mutual support, and respectful collaboration are integral to our daily work
- Modern working environment with benefits like flexible working hours and remote work options
- Dedicated onboarding and ongoing investment in your professional and personal development
- A secure working environment with great people and exciting challenges
In our company we can work completely independently from the office. We enable our employees to work as flexible as possible – in the main office in Minden, in the co-working space, from home or on the road. All the more we appreciate our time together in the office and use it with great impact! But in order to achieve the perfect experience for our team, we attach great importance to extensive on-site training.
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