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Permanent position - Senior Device Development Manager (m/f) Munich Germany,  


Posted on : 08 May 2017

Project Description

Permanent position - Senior Device Development Manager (m/f) Key responsibilitiesPreparation of development, quality and regulatory documents in compliance with regulatory standardsDeveloping/compiling Technical Files and Design DossiersManagement of device development projectsStrategic planning and preparation of regulatory submission documents, interpretation of regulations and compliance with regulatory guidanceDriving risk management activities during development and post-launchPerforming design validation activities, e.g. planning, execution and reporting of Human Factors studiesConsulting with customers regarding quality management and quality control challengesAuditing according to EN ISO 13485 and CFR 820Your profileBachelor / Master in engineering or life sciences or with an equivalent combination of qualification and experienceKnowledge of regulatory guidelines: Medical Device Directive (MDD)  Directive 93/42/EEC, CFR 820, EN ISO 13485 and EN ISO 14971,Ideally with experience in the field of medical devices of at least 3 years (Master) or 5 years (Bachelor)Client-focused approach to workExcellent communication skills (verbally and in writing)Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and training needsAnalytic and business-oriented thinkingAbility to travel locally and internationally, as requiredAbility to work at the client s site, as requiredExcellent command of English and GermanBenefitsWorking for and being part of a fast-growing organizationWork with a high degree of responsibility and independenceFlexibility in terms of working hours and work placeThe time spent in our offices will be in a suburban setting close to lakes and mountains, yet a stone-throw away from Munich (connected by public transportation and highway)Work on attractive and varying projects in different geographies for different clientsBe part of an emerging organization in the explosive growth of the Biosimilar marketAttractive, performance-based compensation package

Locations

Munich Bavaria Germany

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