Job Opportunity
We are seeking a skilled professional to fill the role of Regulatory Affairs Coordinator.
* This position involves providing administrative support to our regulatory team in an engineering office environment.
The ideal candidate will have excellent organizational and communication skills, as well as a strong attention to detail.
Key Responsibilities:
* Provide administrative assistance to regulatory staff including filing, tracking documents, and responding to requests.
* Maintain files, take minutes during meetings, and perform data entry tasks.
* Coordinate incoming and outgoing mail, manage the regulatory inbox, and schedule meetings.
* Prepare and maintain documentation, reports, schedules, databases, spreadsheets, and logs to support functions.
* Support regulatory staff with submissions to regulatory authorities.
Requirements:
* A minimum degree qualification in a relevant Science, Engineering or Quality Assurance discipline is required.
* Prior experience working in a Quality Assurance regulated medical product environment is advantageous.
* A thorough knowledge of FDA 21CFR, ISO, IVDD98/79/EC and international regulatory requirements is essential.
* Excellent interpersonal and communication skills are necessary for success in this role.
* Strong attention to detail and ability to prioritize tasks is crucial.
Location: Killaloe, Ireland
Salary Range: €45,000 - €60,000 per year
Currency: EUR