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Risk Manager - Medical Device - Lab Automation

We recruit for a confidential Medical Device client. Our client is a Global Player and has more than 80 years experience in the field of Lab Automation. Client's 60,000 associates serve customers in more than 125 countries and generated $16.5 billion of revenue in 2016. Client's systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use the life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs.

This challenging position is located in Munich:

Risk Manager - Medical Device - Lab Automation

- Ensure compliance of the risk management process within Business Units
- Interact with client's Risk management community and more specifically with the global Process Owner and represent business unit within the RM Council
- Deploy, plan and perform risk management activities within the organization
- Maintaining, reviewing and approving risk management documentation (in particular Risk Management Plan, Risk Benefit Analysis, Product Safety Reference, System Risk Assessment, Post Launch Risk Assessment etc.) and coordinate the required technical experts for risk assessment workshops;
- Deploy risk management best practice, standard operating procedures and general guidance for the application of risk management in device development;
- Disseminate knowledge and awareness of risk management within the organization;
- Supporting escalation of customer complaints associate to the products to MDR / MDV and/or FSCA;
- Subject Mater Expert for Risk Management during internal and external audits and/or inspections;
Responsible for identifying opportunities for improvement within Risk Management.

- Bachelor’s degree or Master’s degree with 5+ years of experience, preferably in areas of life sciences, engineering, or quality assurance
- Thorough knowledge and expertise in risk management and/or customer complaint management, ideally working experience in the IVD, medical devices or other regulated environment
- Strong knowledge of regulation: ISO13485 and 21CFR 820.demonstrated skills in risk assessment(sFMEA) and root cause analysis
- Excellence in the use of 5 Whys or other appropriate root cause investigation tool(s)
- Ability to work in matrix environment and lead interdisciplinary and cross-cultural team member without direct reporting line
- Ability to quickly establish credibility and trustworthiness with key stakeholders
- Excellent command of verbal and written English
- Goal oriented, interpersonal, self-motivated and team player

If you are interested and qualified, please send us your resume as a Doc, RTF or PDF-File in English.
Kategorie Ingenieur Ansprechpartner BANDAO Unternehmensberatung GmbH
Herr Markus Moser
Schloßbergstraße 1
D-82319 Starnberg
Tel. :+49-8151-555 1 666
Markus Moser
Branche Medizintechnik
Einsatzort München
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