Description
Regulatory Compliance EngineerOur Global Medical Device client is looking for an experienced regulatory affairs professional to help them review their regulatory systems and procedures, support QA projects and drive improved communications across different departments. This role will be part of a wider quality improvement project being carried out across all QA workstreams to drive regulatory compliance to an outstanding level.
Your main responsibilities
• Maintenance and optimisation of the quality management system
• Assisting in strength / weakness analysis of the Quality Management System
• Responsible for compliance to all applicable Standards
• Responsible for label data management and designing and the layout of labels
• Review and approval of processes, createing/revising procedures and work instructions to ensure these processes are correctly documented
• Serving as a checkpoint to ensure procedures are written in an understandable fashion
• Coaching process owners in process improvement
• Leading and assisting Quality Planning projects
• Leading and assisting CAPA projects
• Assising in the development, implementation, and maintenance of electronic workflows
• Surveying Training effectiveness and completion rate, delivering quality trainings
• Coordination of training needs with Manager training and education, error management
Your Qualifications and Experience
• Degree in business or engineering or professional experience in a similar position
• Past experience in procedure writing
• Excellent command of English and German both verbal and written
• Ability to train personnel
• Familiar with a variety of office software packages including MS Word, Power Point, Visio,
• Excel, databases and SAP
• Knowledge of applicable ISO Standards in particular ISO13485, ISO 9001, ISO14971, the Medical Device Directive 93/42/EEC, other relevant European directives and general knowledge of US Quality System Regulations
• Knowledge / background in medical device industry
• Managing projects and processes
• Cross Boundary teamwork
• Strong customer focus
• Good interpersonal skills