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Regulatory Compliance Engineer
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Engineer, Engineering, Support
Projektbeschreibung
Regulatory Compliance Engineer
Our 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, Powerpoint, 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
Our 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, Powerpoint, 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
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges