Company: Hobson Prior
Closing Date: 23 Jan 17
Salary (£): On Application
Benefits: Depending on experience
My client is a leading specialist in digital imaging. As the QA/RA Professional you will ensure quality, regulatory compliance and safety and efficacy of our products and medical devices. Being a member of the development project core teams you will provide guidance and define regulatory plans and strategies.
My client is a leading specialist in digital imaging. As the QA/RA Professional you will ensure quality, regulatory compliance and safety and efficacy of our products and medical devices. Being a member of the development project core teams you will provide guidance and define regulatory plans and strategies. You will be accountable for the implementation of the premarket regulatory procedures, sound application of risk management principles and the compilation of documentation to achieve timely regulatory clearances. At your site you furthermore are supporting the divisional quality system as part of our integrated management system.
You are responsible for:
Assuring regulatory and process conformance for development and maintenance projects as member of cross functional premarket project core teams.
Definition of a Regulatory and Product Quality Strategy
Creation and maintenance of key regulatory deliverables of the projects
Regulatory and CE submissions in cooperation with regional QARA organizations
As risk moderator of development team ensuring that the medical device risk analysis process is followed
Reviewing product documentation to ensure compliance with regulations and signing off on key project related documentation and milestone
Providing compliant design control files and defending pre market activities during external regulatory inspections
Taking actions on process issues for related premarket/design control processes
Identify ongoing training needs and provide training as required
Provide KPI data for internal reporting on project status and regulatory submissions
Supporting the Integrated Management System on site. Performing internal audits as per the global internal audit plan and support external audits
At least 3-5 years’ experience in a regulated industry – preferably medical device, holding a position in quality assurance, regulatory affairs, quality management or project management
Subject matter expert in regulatory affairs with in-depth knowledge of relevant Healthcare quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, Medical Device Directive 93/42/EEC
Operational experience with risk management processes
Ability to analyze, understand, and interpret regulations and quality standards for a more general business audience
Self-starter attitude, strong organizational skills and the ability to meet deadlines
Team player with excellent communication and leadership skills, capable of coaching
Very good German and English verbal and written communication skills, French language is an asset
Please use the form below to apply or contact us for further information on the position. Alternatively, if you know someone that would be interested and suitable, you can refer a friend!
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Hobson Prior Europe GmbH
D4 Platz 3
6039 Root LÃ¤ngenbold
|Tel:||t: +41 (0)41 455 25 60|
|Fax:||f: +41 (0)41 455 25 61|
|Website:||Visit Our Web Site|
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