Regulatory Affairs Administrator

Regulatory Affairs Administrator 

The Company:

My client is the leading global developer and manufacturer of quality control material and software for clinical laboratories based in Ballina, Co Tipperary on the Clare/Tipperary border.

We are sourcing a Regulatory Affairs Administrator join their Team on a contract basis, this role is ideal for someone who is looking to progress their career in Regulatory Affairs sector.

Working in a small team environment you will be responsible for some of the following duties : 

• General administrative skills in an engineering office setting, provides administrative support to regulatory staff for filing & tracking of documents.

• Responds to regulatory staff requests for administrative support as needed.

• Sets up and maintain files, prepares reports, takes minutes during team meetings.

• performs data entry, proofreads, and compiles special reports.

• Receives and distributes incoming mailing and coordinates outgoing mail, including courier services

• Manages the regulatory admin inbox together with other Administrative Associates.

• Schedules meetings and meeting arrangements. Provides meeting support as needed 

• Communicates with both internal and external personnel as required.

• Prepares and maintains documentation, plans, reports, schedules, databases, spreadsheets, logs, etc. to support functions.

• Supports regulatory staff with submissions to regulatory authorities.

• Performs other duties as assigned.

Qualifications:

• Minimum of degree qualification in relevant Science, Engineering or Quality Assurance discipline

• 1+ years’ experience working in a Quality Assurance regulated medical product environment is an advantage

• Thorough knowledge of FDA 21CFR820, ISO 13485, IVDD98/79/EC and international regulatory requirements

• Strong interpersonal skills and the ability to communicate well both verbally and in writing.

• Excellent attention to detail and ability to prioritise.

How to Apply:

If you're interested in applying, or want to know more about this job 1st, contact Sarah Jeanne in CPL Limerick on 087 9077699 / 061 208649 or email your Cv to sarah.kelly@cpl.ie in complete confidence. 

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