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Alba Bioscience Limited：Regulatory Affairs Officer 招聘信息 申请截止日期4月12号
frank1226(2010/4/6 2:15:11) 点击:67318 回复:0 IP:212.* * *
frank1226(2010/4/6 2:15:11) 点击:67318 回复:0 IP:212.* * *
Employer
Alba Bioscience Limited
Job title
Regulatory Affairs Officer (Ref RAO 2.1)
Closing date
12/04/2010
No of posts
2
Job categories
Administration
Paid / unpaid
Paid
Salary
£18,000 - £24,000
Job description
The primary role of the 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.
After suitable training, the Regulatory Affairs Officer must maintain 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.
Company Information
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, freeze drying and packaging.
All manufacturing is carried out according to current Good Manufacturing Practice in state of the art facilities located in Edinburgh, Scotland.
Skills and Qualifications
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.
How to apply
Send current CV to:
HR Department,
and covering Letter to: Alba Bioscience Limited,
21 Ellen's Glen Road,
Edinburgh, EH17 7QT
Alternatively, please e-mail your CV and covering letter to:
[email protected] Please quote Reference (RAO 2.1)
Subject(s)
Biological Sciences
Location(s)
Edinburgh and East Scotland
Additional location details
Edinburgh
Full-time/part-time
Full-time
Permanent/Temporary
Unspecified
Start date
Now
Additional timing information:
Approximately 4-5 weeks
Alba Bioscience Limited
Job title
Regulatory Affairs Officer (Ref RAO 2.1)
Closing date
12/04/2010
No of posts
2
Job categories
Administration
Paid / unpaid
Paid
Salary
£18,000 - £24,000
Job description
The primary role of the 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.
After suitable training, the Regulatory Affairs Officer must maintain 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.
Company Information
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, freeze drying and packaging.
All manufacturing is carried out according to current Good Manufacturing Practice in state of the art facilities located in Edinburgh, Scotland.
Skills and Qualifications
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.
How to apply
Send current CV to:
HR Department,
and covering Letter to: Alba Bioscience Limited,
21 Ellen's Glen Road,
Edinburgh, EH17 7QT
Alternatively, please e-mail your CV and covering letter to:
[email protected] Please quote Reference (RAO 2.1) Subject(s)
Biological Sciences
Location(s)
Edinburgh and East Scotland
Additional location details
Edinburgh
Full-time/part-time
Full-time
Permanent/Temporary
Unspecified
Start date
Now
Additional timing information:
Approximately 4-5 weeks
