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Quality Assurance and Regulatory Affairs Manager- Phagenesis Ltd
An experienced quality/regulatory professional is required for an exciting and fast growing young medical devices company. Reporting to the Chief Operating Officer, the Quality Assurance and Regulatory Affairs Manager (QA/RA) will be accountable for creating, implementing and managing all aspects of a Quality Management system Compliant with ISO 13485:2003 and USA FDA Quality System Regulations, achieving and maintaining certification to ISO 13485:2003 and preparing and managing product submissions for regulatory clearances in the EU, USA and other geographic areas as required. The ideal candidate will have worked for three to five years within a medical device environment and will have the following experience:
1) Establishing, managing and maintaining Quality Management Systems that are compliant with ISO 13485:2003 - Quality System Standard for Medical Devices.
2) Conducting internal and / or external regulatory audits as well as managing third party internal audits.
3) Understanding EC Medical Device Directive requirements - in particular, detailed knowledge of IEC 60601 (electrical) requirements would be an advantage.
4) Preparing EC Technical Files and Design History Files.
5) Preparing USA FDA submissions for regulatory clearance
The QA/RA Manager will work from the Phagenesis office in Manchester but must be able to travel to carry out supplier audits, to meet with regulatory bodies and attend meetings as required by management. As part of a small team, the successful candidate will have the opportunity to expand their skills and responsibilities as far as their ambition and ability can take them. We offer a highly competitive package based on salary and share options, and a chance to build a career with a successful high-growth business. Phagenesis is an equal opportunities employer.
Please send covering letter and CV to:
Dr Conor Mulrooney
conor.mulrooney@phagenesis.com
Tel: 07545148993
Closing Date: 24th September 2010
No recruitment agencies please
Service Engineer / Warehouse Vacancy
MESM specialise in the Sourcing, Supply, Service and Calibration of medical equipment for Hospitals, Laboratories and Clinical Research Organisations. MESM Service Ltd. provides Calibration, Maintenance and Support Services for medical and scientific equipment to Hospitals, Laboratories and Clinical Research Organisations on a global basis.
Based in Lancashire, UK our main operations are conducted from Chorley, where sales & marketing, purchase, service and warehouse operations reside.
The Service / Warehouse Engineer will have responsibility for Service, Calibration and Repair of Medical equipment for MESM. Provide technical Support for customers and be responsible for receiving, packaging and shipment of product.
Apply in writing to Mike Woods, Service Director, MESM, Logistics House, Buckshaw Avenue, Chorley, PR6 7AJ or alternatively by email to mikew@mesm.co.uk.Product Researcher / Developer with Scientific Writing
Proteintech Europe are looking to recruit a motivated scientist to join the team at Manchester Science Park.
Main Job Responsibilities will include:
• Researching existing products
• Researching new technology / methodology
• Investigating new areas of research
• Researching new products for Lab team
• Reading publications by customers
• Researching Signal Pathways for marketing
• Creating content for Blog, newsletter and other social media
• Updating existing product information
The successful candidate will have strong interpersonal and excellent communication skills. There will be opportunities to travel both nationally and internationally throughout the year, so they will need to be able to spend periods of time away from home.
Minimum Qualification
PhD in Life Sciences
Please send a covering letter and CV to:
Ms Libby Witherden, European Business Manager
Email: libby@ptglab.com
Tel: 0161 226 6144
Closing Date: Monday 4 October
Application Scientist
Farfield Group Ltd have an immediate vacancy for an Application Scientist to work on label free bioassay design using Farfield's proprietary Dual Polarisation Interferometer instrumentation. In addition to the technical aspects of application development, the role will include a high level of customer interface and representation of Farfield's product and technologies to an industrial and academic market worldwide. The successful candidate will ideally be qualified to PhD level with a life science or chemistry background and have experience working with a range of analytical equipment.
For further details contact Marcus Swann at mswann@farfield-group.com or phone 0161 436 9700
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