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REG AFFAIRS ASSOCIATE
Company:MORGAN MCKINLEY |
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Job Reference Number |
14567091 |
Client ID: |
RI/905929ML |
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Posted On: |
Feb 8 2012 |
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Location: |
TIPPERARY SOUTH, TIPPERARY |
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Job Type: |
Contract |
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Salary: |
EUR40K - EUR55K /A |
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Benefits: |
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Our client, a leading Medical Device manufacterer in Tipperary have a requirement for a Degree qualified Reg Affairs professional to join them on a 21 month fixed term contract.
Responsibilities:
- Conducts audits of the internal quality system, as per defined audit schedule
- Creates audit checklist based on the assigned audit area, reflecting all applicable regulations and quality system/procedural requirements and obtains approval from Lead Auditor as appropriate
- Evaluates the adequacy and compliance of systems, operations and practices against regulations and company documentation
- Formulates and documents non conformities and obtains concurrance with responsible management
- Tracks issues through to closure including reviewing the corrective action taken
Requirements:
- Degree qualified with 4 + years experience in a similar role within Medical Device essential.
- Previous experience in setting up company as legal manufacturer beneficial along with strong documentation management and experience using compliance systems.
- Applicants must have a strong understanding of regulatory practices around notified bodies.
To apply for this role please contact Maeve Lawlor in Morgan McKinley on 051 309650 or email your cv in confidence to mlawlor@morganmckinley.ie
