Regulatory Affairs Coordinator

Regulatory Affairs Coordinator (Contract, EMEA Region)

We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to join our team and provide essential administrative project support for our ongoing regulatory transition activities. This is an excellent opportunity for someone with prior experience in managing high-volume documentation within the medical device sector, especially those with knowledge of AGILE systems.

Key Responsibilities:

Collect, organize, and maintain regulatory documentation (e.g., technical files, IFUs, labels, product portfolios)
Support MDR/IM updates in collaboration with local EMEA Regulatory Affairs colleagues
Work within document management systems such as Windchill, MDRIM, and AGILE
Raise and track internal requests, ensuring timely follow-up and resolution

Preferred Experience:

Prior hands-on experience with the AGILE system
Ability to quickly adapt to complex regulatory environments and manage multiple priorities

Position Details:

Start Date: ASAP
Contract Duration: 12 months from start date
Location/Time Zone: EMEA region preferred; applicants from Turkey, South Africa, and Egypt are welcome

If you are ready to support high-impact regulatory projects and have the documented experience we seek, we invite you to apply now and join a dynamic, global team!