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 Administratorjoin their Teamon 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 or email your Cv to in complete confidence.
#Limerick25 Skills: 'Regulatory Affairs' Administrator 'Documentation Control'