They are a young consultancy company, started in 2014 with a focus on supporting product development and compliance projects in the medical device and pharma/biotech industries.
Preparation of development, quality and regulatory documents in compliance with regulatory standards Developing/compiling Technical Files and Design Dossiers Management of device development projects Strategic planning and preparation of regulatory submission documents, interpretation of regulations and compliance with regulatory guidance Driving risk management activities during development and post-launch Performing design validation activities, e.g. planning, execution and reporting of Human Factors studies Consulting with customers regarding quality management and quality control challenges Auditing according to EN ISO 13485 and CFR 820
Bachelor / Master in engineering or life sciences or with an equivalent combination of qualification and experience Knowledge 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 work Excellent communication skills (verbally and in writing) Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and training needs Analytic and business-oriented thinking Ability to work at the client's site, as required Excellent command of English and German
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