CODAN Medizinische Geräte GmbH specialises in the manufacture and distribution of disposable medical transfer systems. With more than 60 years of research and development, CODAN is a respected supplier of high-quality medical devices. We have some 480 employees working on the development and manufacture of these successful medical devices at our headquarters in Lensahn.

Our Quality Assurance department has an immediate vacancy for an

Engineer/Technician – Medical Technology – as risk manager for medical devices (m/f/other)

Risk manager for medical devices (m/f/other)

Your tasks:

• Planning, organisation, creation and documentation of risk management activities, such as risk analyses and assessments for non-active medical devices
• Development and maintenance of the risk management process for medical devices
• Contact person (m/f/other) for collaboration with the interfaces to risk management: clinical evaluation, post-market surveillance, development, FMEA, biocompatibility, manufacturer information (instructions for use/accompanying documents)
• Application and implementation of regulatory and normative requirements in connection with the risk management for medical devices, e.g. Regulation (EU) 2017/745 for medical devices (MDR) or DIN EN ISO 14971
• Moderation, organisation and coordination of risk management

Your qualifications:

• Degree in the field of engineering (e.g. medical technology) or equivalent vocational qualification
• Several years of professional experience in risk management for medical devices according to DIN EN ISO 14971
• Ideally regulatory knowledge in the field of medical technology, e.g. Directive 93/42/EEC on medical devices (MDD) or Regulation (EU) 2017/745 on medical devices (MDR)
• Ability to understanding complexities and problem-solving skills
• Analytical, structured and pragmatic approach to tasks
• High level of self-reliance, dependability and diligence
• Open communication style, good teamworking and organisational skills
• Good IT application skills, e.g. Microsoft Office, ERP system
• Good spoken and written German and English

If our job advertisement has aroused your interest, do not hesitate to get in touch. Please send your application by email. Contact person: Tim Lundbeck, Human Resources Manager

CODAN Medizinische Geräte GmbH · Stig Husted-Andersen Straße 11 · D-23738 Lensahn · Tel. +49 (0) 43 63 · 51 11 · Fax +49 (0) 43 63 · 51 12 14 · E-Mail: personal@codan.de · www.codancompanies.com