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Regulatory Affairs Specialist

posted on 13/05/2003
location Highland Region Inverness
description CLIENT - Inverness based medical devices manufacturer - part of global medical products corporation ROLE To assist RA Director to meet Domestic and International RA requirements affecting Diabetes Monitoring Products Ø To prepare in consultation with RA Director International and Domestic Regulatory Strategies for new and modified product submissions. Ø To represent RA on project teams and to interface with Research, Development, Operations, QA, Manufacturing and Marketing. Ø To prepare, submit and maintain product submissions, 510(k)’s/PMAs, CE Mark technical dossiers and registration files. Ø Monitor and communicate on new and changing regulations. Ø Review internal change requests to assess impact on submitted registration documents. Ø Identify process improvement opportunities and progress change. Ø To review product labelling for compliance.
skills - Degree in scientific field - Knowledge of US FDA regulations and GMP compliance, also EU IVD Medical Device Directives - Minimum of 3 years experience in RA environment preparing product submissions - Able to communicate effectively with government agencies and internal and external customers. - Able to meet deadlines and to work independently - self starter and multitasker - Must have working knowledge of Microsoft Windows Software; Word, Excel, Access and PowerPoint - Team player, with strong interpersonal skills. - Familiar with ISO 9001 requirements, and knowledge of International Regulatory Requirements - Excellent written and verbal communication - Familiar with PMA (Pre Market Approval Applications) /IDE (Investigational Device Exemption ) Requirements - Technical experience in R&D - Career - desire to pursue regulatory career
 

ASP .net Developer

posted on 04/04/2003
location UK Scotland, Glasgow
description ASP.net Developer - £35K + benefits- Scotland Opportunity to join an AIM listed digital marketing, communications and animation company as ASP.net Developer. My client is a pioneering animation company who have created a groundbreaking piece of creative technology, which provides an intelligent interface between digital technology and the user through highly expressive and human-like 3D characters. At the heart of the technology lies their real time character animation engine which allows developers to integrate realistic virtual characters with voice recognition and artificial intelligence into applications deployed across web, digital kiosk, TV and mobile technology, to name a few. Based on their proprietary software, the company have developed a portfolio of products and services targeted for three vertical industries the financial services industry, the public sector, and the telecoms, media and technology markets. The core technology will also be available to the development community, allowing them to integrate interactive virtual characters into a wide range of new and existing software applications. A leader in intelligent communications, the company offer everything from off-the-shelf applications designed specifically for the target industries, to entirely bespoke solutions. Their expertise spans all multimedia platforms, kiosks, web, CD and even TV meaning that they can offer complete business solutions that deliver real business benefits, improve customer relationships and help to generate revenue. We now have an immediate requirement for an ASP.net Developer to lead the development of applications for websites, mobile applications and digital kiosks. This person will be involved in all stages of projects from initial requirement gathering, definition of functional and technical specifications through to hands on development and final delivery. We need someone with experience of working with clients and managing a small technical team, which will involve project scoping, resource allocation and day to day man management - recruitment, team motivation, etc.   To qualify, you will have at least 4 years experience of development in an ASP environment, with exposure to .net technologies, C sharp, SQL server and database design using various database systems. You will have a comprehensive understanding of multimedia technology gained in a software, web or product development environment and be familiar with CMS. It is expexted that you will have a good knowledge of front-end technologies and how they integrate with ASP, preferably with some hands on experience. Ideally, you will have overseen or directly managed a sizeable project budget. At the least, you will have experience of leading a small technical team and be involved in the production of functional specs, technical specs, architecture and project plans.  You must have a degree of commercial acumen, be able to manage people and communicate effectively with external customers, both written and verbally. Previous experience in quality assurance and standards would be advantageous. Most importantly, you will have the ability to lead and motivate other inspirationally. The company are based in a modern, spacious office in the city centre of Glasgow and offer a relaxed and friendly working environment. The package on offer includes a basic salary of £30-35, share participation, private healthcare, contributory pension, etc. The opportunity for accreditation or certification is also possible - MCSD. If you would like to discuss your experience, or find out more about the company please feel free to contact me. Alternatively, email a CV to be considered for this or any future roles. Never been to Scotland? Turn up your sound, and follow one of these links for a taster... low bandwidth : http://www.warkclements.co.uk/video/glasgow_low/glasgow_low5.mov medium bandwidth : http://www.warkclements.co.uk/video/glasgow_med/glasgow_med5.mov high bandwidth : http://www.warkclements.co.uk/video/glasgow_high/glasgow_high5.mov Thanks Robert Towie 07974 257 253 roberttowie@msn.com  
skills To qualify, you will have at least 4 years experience of development in an ASP environment, with exposure to .net technologies, C sharp, SQL server and database design using various database systems. You will have a comprehensive understanding of multimedia technology gained in a software, web or product development environment and be familiar with CMS. It is expexted that you will have a good knowledge of front-end technologies and how they integrate with ASP, preferably with some hands on experience. Ideally, you will have overseen or directly managed a sizeable project budget. At the least, you will have experience of leading a small technical team and be involved in the production of functional specs, technical specs, architecture and project plans. You must have a degree of commercial acumen, be able to manage people and communicate effectively with external customers, both written and verbally. Previous experience in quality assurance and standards would be advantageous. Most importantly, you will have the ability to lead and motivate other inspirationally.
 

Operations Manager

posted on 04/04/2003
location UK Scotland, Glasgow
description Operations Manager - £40K - Scotland Opportunity to join an AIM listed digital marketing, communications and animation company as Operations Manager. My client is a pioneering animation company who have created a groundbreaking piece of creative technology, which provides an intelligent interface between digital technology and the user through highly expressive and human-like 3D characters. At the heart of the technology lies their real time character animation engine which allows developers to integrate realistic virtual characters with voice recognition and artificial intelligence into applications deployed across web, digital kiosk, TV and mobile technology, to name a few. Based on their proprietary software, the company have developed a portfolio of products and services targeted for three vertical industries – the financial services industry, the public sector, and the telecoms, media and technology markets. The core technology will also be available to the development community, allowing them to integrate interactive virtual characters into a wide range of new and existing software applications. A leader in intelligent communications, the company offer everything from off-the-shelf applications designed specifically for the target industries, to entirely bespoke solutions. Their expertise spans all multimedia platforms, kiosks, web, CD and even TV meaning that they can offer complete business solutions that deliver real business benefits, improve customer relationships and help to generate revenue. We now have an immediate requirement for an Operations Manager who will be responsible for managing the operational team to ensure that the appropriate resources are in place and efficiently allocated to enable the business to achieve its operational targets. The Operations Manager will work closely with the Board in setting and managing operational budgets and resources, and be responsible for recruiting training and managing the operational team. In addition, they will be expected to identify skills gaps, define roles and support ongoing recruitment programs as well as assist with market planning activity. To qualify, you will have at least 4 years experience of Operations Management gained in a software, web or product development environment. You will have a comprehensive understanding of multimedia technology including web, mobile or kiosk and have overseen or directly managed a sizeable operations or project budget. You must have a degree of commercial acumen, be able to manage people and communicate effectively with external customers, both written and verbally. Previous experience in quality assurance and standards would be advantageous. Ideally, you will have the ability to lead and motivate other inspirationally and have a degree level qualification in business, technology or management. The company are based in a modern, spacious office in the city centre and offer a relaxed and friendly working environment. The package on offer includes a basic salary of £35-40K, share participation, private healthcare, contributory pension, etc. If you would like to discuss your experience, or find out more about the company please feel free to contact me. Alternatively, email a CV to be considered for this or any future roles. Never been to scotland? Turn up your sound and follow a link for a taster... low bandwidth - http://www.warkclements.co.uk/video/glasgow_low/glasgow_low5.mov medium - http://www.warkclements.co.uk/video/glasgow_med/glasgow_med5.mov high - http://www.warkclements.co.uk/video/glasgow_high/glasgow_high5.mov Thanks Robert Towie   07974 257 253 roberttowie@msn.com
skills We now have an immediate requirement for an Operations Manager who will be responsible for managing the operational team to ensure that the appropriate resources are in place and efficiently allocated to enable the business to achieve its operational targets. The Operations Manager will work closely with the Board in setting and managing operational budgets and resources, and be responsible for recruiting training and managing the operational team. In addition, they will be expected to identify skills gaps, define roles and support ongoing recruitment programs as well as assist with market planning activity. To qualify, you will have at least 4 years experience of Operations Management gained in a software, web or product development environment. You will have a comprehensive understanding of multimedia technology including web, mobile or kiosk and have overseen or directly managed a sizeable operations or project budget. You must have a degree of commercial acumen, be able to manage people and communicate effectively with external customers, both written and verbally. Previous experience in quality assurance and standards would be advantageous. Ideally, you will have the ability to lead and motivate other inspirationally and have a degree level qualification in business, technology or management.
 

IT Support Specialist

posted on 11/06/2002
location Central Scotland Glasgow
description
skills Our client, who are a leading Glasgow based Marketing Consultancy are seeking an IT Support Analyst with a strong background in supporting Windows NT, 2000 and 98 coupled with excellent TCP/IP skills and some exposure to Cisco Routers. Any knowledge of Unix would be a distinct advantage. This is a young, innovative company who place a strong focus on the importance of networks within the company.