Alba Bioscience Limited Senior Regulatory Affairs Officer Salarypackage

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Alba Bioscience Limited Senior Regulatory Affairs Officer Salary/package - Competitive Alba Bioscience Limited is

Alba Bioscience Limited Senior Regulatory Affairs Officer Salary/package - Competitive Alba Bioscience Limited is a well-established bio-manufacturing organisation, with an internationally recognised product portfolio. The product range includes in vitro diagnostics for immunohaematology, immunology and haematology. Many products incorporate polyclonal antisera or monoclonal antibodies. The organisation offers contract services to the bioscience industry and currently manufactures products for major global players in the Life Sciences sectors. Development and manufacturing capabilities include pilot and large-scale mammalian cell culture, polyclonal antibody production, product formulation, liquid fill and packaging. All manufacturing is carried out according to current Good Manufacturing Practice in facilities located at two sites in Edinburgh area. Applications are sought for the above vacancy within the Regulatory Affairs Department based at Ellen’s Glen Road, Edinburgh. The main duties of this post will be to manage, prepare and maintain regulatory documentation to enable the Company to comply with ISO 9001 and ISO 13485 standards and to ensure on-going regulatory compliance with the 98/79/EC IVD Directive, FDA Code of Federal Regulations and Canadian Medical Device Regulations, Part 1. You will be required to be qualified to degree level in a relevant discipline and have an appropriate level of experience in a Regulatory Affairs environment. Ideally you should also have specialist knowledge of in vitro diagnostic medical devices and an understanding of the operation of a medical device manufacturing establishment and proven track record in Biologics. Good communications skills and a working knowledge of core IT packages is essential. Our benefits package includes competitive salary, bonus and pension scheme. To Apply for this position, please email your current CV and covering Letter to [email protected] co. uk quoting Reference (SRAO 1. 1) Alternatively, Please post your current CV and covering letter to HR Department, Alba Bioscience Limited, 21 Ellen’s Glen Road, Edinburgh, EH 17 7 QT Closing date is 16 April 2012 Alba Bioscience Limited Ellen’s Glen Road Edinburgh, EH 17 7 QT United Kingdom Tel: +44 (0) 131 536 5907 Fax: +44 (0) 131 536 5897 E-Mail: customer. [email protected] co. uk Web: www. albabioscience. co. uk