Regulatory Affairs Administrator

Cpl Healthcare; Killaloe; On-site; EUR 35,000 - 50,000; Full time

Job summary

A leading company in quality control material and software for clinical laboratories is seeking a Regulatory Affairs Administrator based in Ballina, Co Tipperary. The role involves providing administrative support to the regulatory team, maintaining documentation, and ensuring compliance with regulatory submissions. Candidates should have a relevant degree and experience in a Quality Assurance environment with strong communication skills. This is an ideal opportunity for someone looking to progress their career in Regulatory Affairs.

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.

Responsibilities

• Provides administrative support to regulatory staff for filing & tracking of documents.
• Responds to regulatory staff requests for administrative support as needed.
• Sets up and maintains 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.

Skills

Excellent attention to detail

Strong interpersonal skills

Ability to communicate well verbally

Ability to communicate well in writing

Education

Degree qualification in relevant Science

Engineering or Quality Assurance discipline

Job description

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 087 9077699 / 061 208649 or email your Cv to [e-mail] in complete confidence.

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