Regulatory Affairs Administrator

CPL
Job title: Regulatory Affairs Administrator
Company: CPL
Job description: Regulatory Affairs AdministratorThe 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 [email protected] in complete confidence.#Limerick25
Expected salary: €30000 – 35000 per year
Location: Killaloe, Co Clare
Job date: Wed, 23 Jul 2025 05:30:47 GMT
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