Regulatory Affairs Professional
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The role of Regulatory Affairs Administrator is key to ensuring the company's products comply with regulatory requirements.
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Working in a small team environment, you will be responsible for some of the following duties:
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1. General administrative skills in an engineering office setting, providing administrative support to regulatory staff for filing and tracking of documents.
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2. Responding to regulatory staff requests for administrative support as needed.
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3. Sets up and maintain files, prepares reports, takes minutes during team meetings.
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4. Performs data entry, proofreads, and compiles special reports.
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5. Receives and distributes incoming mail and coordinates outgoing mail, including courier services.
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7. Communicates with both internal and external personnel as required.
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8. Prepares and maintains documentation, plans, reports, schedules, databases, spreadsheets, logs, etc. to support functions.
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9. Supports regulatory staff with submissions to regulatory authorities.
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10. Performs other duties as assigned.
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11. Requirements:
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12. Minimum degree qualification in relevant Science, Engineering or Quality Assurance discipline.
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13. 1+ years' experience working in a Quality Assurance regulated medical product environment is an advantage.
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14. Thorough knowledge of FDA 21CFR, ISO, IVDD98/79/EC and international regulatory requirements.
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15. Strong interpersonal skills and the ability to communicate well both verbally and in writing.
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16. Excellent attention to detail and ability to prioritise.
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17. How to Proceed:
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If you're interested in this opportunity, contact CPL Limerick to discuss further.
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