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Vacancy details
Vacancy description:
Job Code:
PCNWEng
Job Title:
Regulatory Affairs 3 - 6 Month Contract
Job Category:
Regulatory And Drug Safety
Contract:
Locum/Temporary
Discipline:
Regulatory Affairs
Country:
United Kingdom
Location:
South Yorkshire, West Yorkshire, Yorkshire
Min experience:
4 years
Annual salary:
Negotiable (35 - 50 £)
Apply by:
08 Jun 2008
Core Competency: European, Medical Device products .
Experience required: 5 years Regulatory Affairs experience
Key responsibilities:
To provide regulatory expertise in the research, development and marketing of Wound Management Medical Device products and to ensure that regulatory approvals are obtained and maintained in accordance with the business plans.
• To compile, or supervise the compilation of, regulatory dossiers/technical files in accordance with EU, US or other national requirements for the approval of products/clinical trial clearances.
• To provide regulatory advice to project teams engaged in the development of new products to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.
• In relation to the above, to interpret individual country legislation.
• Also in relation to the above to analyse, where appropriate, regulatory options and to advise on regulatory strategy taking into consideration business plans.
KEY CHALLENGES
• Maintaining effective progress of a range of projects within the overall department and company objectives.
• Building effective working relationships with key personnel both internally and externally.
• Managing project and regulatory involvement with support as required.
• Developing a pro-active regulatory support service to the company.
If this role is of interest, please call me, Aaron on my direct line 0207 440 0636 as soon as possible or send your CV to a.demello@proclinical.co.uk
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