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Matchtech Group Plc
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| Company Name: | Matchtech Group Plc | |||||
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| Industry Sectors | Manufacturing Mechanical Engineering | |||||
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| Job Title | Project Regulatory Affairs Specialist | |||||
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| Job Ref | 169265EGP | |||||
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| Salary | £30000 - £45000 per annum | |||||
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| Position Type | Permanent | |||||
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| Country | United Kingdom | |||||
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| Region | England | |||||
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| County | Cambridgeshire | |||||
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| Town | Cambridge | |||||
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| Job Description: | ||
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| My client develops breakthrough products, create and license intellectual property, and provide business consulting in technology critical issues, for clients world-wide. They currently have a requirement for a Project Regulatory Affairs Specialist. Main purpose of the job To take a leading role in the regulatory compliance aspects of multi-disciplinary device development projects in the field of drug delivery products, in-vitro diagnostics, and surgical products. The position will require you to apply your regulatory compliance skills to the development of world-leading medical products for our clients around the globe. Type of work undertaken by the division/group The Medical Technology Division undertakes the development of innovative medical devices and equipment from concept to prototype manufacture, often incorporating considerable technical challenges, in the three focus areas of: Medical diagnostics and instrumentation Surgical products and medical systems Drug delivery devices Our work ranges from undertaking complete product developments from concept to market, to providing consulting services for our clients on their technology, strategy or development processes. The division undertakes both client funded and internally funded projects. Specific responsibilities This position involves taking the lead role on regulatory compliance within development projects with exposure to all aspects of development from contract negotiation to final delivery. You will be involved in advising the project manager on the quality management system that needs to be in-place for any given project, and the implication this has for the execution of specific engineering design tasks. Significant project management tasks may also be a key part of the role. You will use your strong regulatory expertise to develop relationships with current and future clients by understanding their needs and by assisting in writing proposals to define the work programmes. You will provide a regulatory point of contact within the company for clients. You will manage tasks within projects requiring delivery within tight timescales and budgets, managing both internal and external resources. Your specific responsibilities will include: Identification of product classification and approval authority Definition of regulatory strategy for product or system developments Definition of specific quality management processes, within our existing ISO 9001 system, to achieve regulatory compliance Identification of compliance tasks in the overall development plan Preparation of project quality, risk management, verification and validation plans Identification and preparation of design verification protocols Preparation of verification and validation reports Identifying process validation requirements To apply for this position, candidates must be eligible to live and work in the UK Matchtech Group Plc is acting as an Employment Agency in relation to this vacancy. | ||