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Regulatory Affairs Analyst

Quality & Laboratory
Cork
Siobhán Lane
Contract
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Job Reference: JO-2006-65217_1591960317

Summary:

Responsibilities:



  • Responsible for the tracking and maintenance of accurate Registration status for products.

  • Responsible for the complete coordination and preparation of Registration Dossiers for global registration purposes.

  • Support the generation of Global Registration Surveys and collation of responses and requirements from RA Affiliates.

  • Responsible for weekly and monthly reporting of registration status.

  • Support product and process change control activities for impact on current regulatory filings.

  • Support the maintenance of Regulatory procedures.

  • Support the coordination of Global Country labeling requirements

  • Support the maintenance of Regulatory Department metrics.

  • Support Regulatory inspections at the site as directed.



Requirements:



  • Bachelor degree in Science

  • 2 years' plus experience in a Medical Device / Pharmaceutical industry.

  • Good attention to detail,

  • Flexible/adaptable to change



Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


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Siobhán Lane
Siobhán Lane
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Quality & Laboratory
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