Job Description
The Regulatory Affairs team is responsible for ensuring the company's innovative medical technologies reach the market in compliance with regulatory requirements. As a key member of this team, the RA Coordinator plays a vital role in providing administrative support for various regulatory activities related to global registrations.
Key Responsibilities:
* Provide general administrative support for regulatory project management by assisting with tracking project status and maintaining tracking tools.
* Effectively manage multiple competing priorities and work in a fast-paced, regulated environment.
* Coordinate meetings with colleagues at both local and regional levels and check the project status.
* Assist with creation and reporting of department and project-related metrics.
* Assist with the collection of project-related documentation and assist with preparation of regulatory submissions.
* Liaise with subject matter experts to collect information and communicate with team members.
* Assist with notarization, legalization, and apostille process for regulatory documentation.
* Collaborate with other project leads to share project status and metrics.
* Assist in auditing, editing, and publishing of regulatory submissions as appropriate.
Requirements
To be successful in this role, you will need:
* Ability to plan and schedule multiple priorities concurrently.
* Ability to review, collate, and summarize scientific and technical data.
* Good problem-solving and analytical skills.
* Good written and oral communication skills.
Education and Qualifications
A Leaving Certificate or equivalent is required, with an associate's degree or bachelor's degree preferred.
Benefits
This role offers a competitive salary range, benefits, and opportunities for growth and development.