Alba Bioscience Limited

1
The Senior Regulatory Affairs Officer
must provide expert advice to Alba Bioscience
Staff and maintain a specialist knowledge of
regulatory affairs as applied to the manufacture
of diagnostic devices, as the role requires
liaising with regulatory agencies and external
customers/distributors to provide information to
support regulatory processes, to confirm
compliance issues and advise as appropriate. A
relevant degree and/or relevant work experience
in a regulatory affairs environment is required.
The successful candidate must have good
organisational skills and be proficient with the
use of core IT packages i.e. MS Office. Our
benefits package includes competitive salary,
bonus and pension scheme. To apply for this
position, please email your current CV and
covering letter to HR_at_albabioscience.co.uk
quoting Reference (SRA1.1) Alternatively,
Please post your current CV and covering letter
to HR Department, Alba Bioscience
Limited, 21 Ellens Glen Road, Edinburgh,
EH17 7QT Closing date is 20 January 2012 Alba
Bioscience will try to contact all applicants to
inform them of the progress of their application.
However, if you have not heard from us by 3
February 2012, you should assume that your
application has not been successful.
Alba Bioscience Limited SENIOR REGULATORY AFFAIRS
OFFICER Competitive Salary/package
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 Quality Regulatory Affairs
Department based at Ellens Glen Road, Edinburgh.
The primary role of the Senior Regulatory
Affairs Officer is to compile product information
for the preparation of regulatory dossiers to
support product licence applications and their
maintenance for worldwide regulatory authorities
in compliance with ISO9001 and ISO13485, the IVD
Directive 98/79/EC, FDA 21 Code of Federal
Regulations (CFRs) and Canadian Medical Device
Regulations (CMDR), Part 1.