Job Title: Regulatory Affairs Coordinator
My client is the leading developer and manufacturer of quality control material and software for clinical laboratories based in Ireland.
This role is ideal for someone looking to progress their career in regulatory affairs sector.
* Provide administrative support to regulatory staff for filing and tracking of documents.
* Respond to regulatory staff requests for administrative support as needed.
* Set up and maintain files, prepare reports, take minutes during team meetings.
* Perform data entry, proofreading, and compile special reports.
* Receive and distribute incoming mail, coordinate outgoing mail, including courier services.
* Manage the regulatory admin inbox together with other administrative associates.
* Schedule meetings and meeting arrangements. Provide meeting support as needed.
* Communicate with both internal and external personnel as required.
* Prepare and maintain documentation, plans, reports, schedules, databases, spreadsheets, logs, etc. to support functions.
* Support regulatory staff with submissions to regulatory authorities.
* Perform other duties as assigned.
Qualifications: A minimum of a degree qualification in a relevant science or quality assurance discipline is required. 1+ years' experience working in a quality assurance regulated medical product environment is an advantage.
Key skills include:
* Thorough knowledge of FDA regulations, ISO standards, 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 prioritize.