Regulatory Affairs Administrator
- Limerick Ballina, Co Tipperary
- Temporary
- Full-time
- 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.
- 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.