Manager / Sr. Manager Riskmanagement (m/w/d)

Based in Munich, our client is an international company involved in the development, production, and distribution of medical devices.

Our client is currently looking for a candidate for development and implementation of manufacturing processes.

If you are looking for a new challenge and are familiar within risk management, I am looking forward to our conversation.

Your tasks for this position:

Responsibility for the company-wide risk & usability management for technically complex medical devices in the field of ophthalmology
Ensuring compliance with the requirements of the risk and usability oriented development processes
Control of the risk management process according to EN ISO 14971 and usability of medical devices according to EN 60601-6 and EN 62366
Preparation of risk management plans and planning, organisation and implementation of risk analyses in development projects
Assessment of product risks as well as coordination, monitoring and support in the implementation of measures to reduce risks
Creation and maintenance of risk and usability files in accordance with regulatory requirements throughout the entire product life cycle
Supporting case management in the evaluation of complaints, error messages and CAPAs
Carrying out FMEAs
Analysis of use case scenarios and user interface requirements
Conceptual design, organisation, implementation, evaluation and documentation of formative and summative usability tests according to normative requirements
Continuous improvement of the product risk management and usability process
Organisation and implementation of internal training in the areas of risk management and usability

What is expected

Successfully completed degree in engineering (electrical engineering, mechanical engineering, physics) or comparable qualification
Several years of professional experience in the areas of risk management and usability engineering in the field of medical technology
Sound knowledge in the application of relevant regulations and standards (e.g. MDD, MDR, EN ISO 14971, EN ISO 13485, 21CFR820, EN 60601-6, EN 62366)
Knowledge of functional safety
Strong affinity for technically complex medical devices
Ability to moderate cross-functional teams in the context of risk management and usability Engineering
Convincing personality with strong communication skills and a high degree of assertiveness and organisational talent
Analytical, structured and solution-oriented approach to work
Collaborative work style and enjoy working in multidisciplinary teams
Very good knowledge of German and English, both written and spoken

Application process

Curriculum vitae to my e-mail: p.roussos@sciproglobal.de
Telephone call with presentation of the company
I am your contact person for the entire application process (interviews to contract negotiations) i.e. you do not have to apply yourself
Discussion of other exclusive positions that fit your profile

My contact details

I am looking forward to your application!

Riskmanager Medical Device (m/w/d)