Regulatory Affairs Specialist
About the role
For our client, a major multinational company, we are looking for a Regulatory Affairs Specialist to join their team! You will manage the regulatory compliance and product lifecycle of medical devices within a global framework. This role involves close collaboration with R&D and Marketing teams across Switzerland, the US, and Japan to ensure market access.
This role focuses on ensuring that all medical devices comply with international regulations while managing the technical documentation and communication with health authorities throughout the product lifecycle.
Work tasks
* Compile and submit regulatory dossiers and technical files to notified bodies and international partners.
* Ensure documentation and processes meet Medical Device Regulation (MDR) requirements.
* Manage the regulatory lifecycle of products from development through to market launch.
* Perform regulatory impact assessments for product modifications via change control processes.
* Review and approve promotional materials and labeling to ensure regulatory compliance.
* Manage Materiovigilance reporting and update the EUDAMED database (UDI implementation).
* Support audits and inspections by providing required documentation to health authorities.
We are looking for
* Experience in regulatory affairs within the medical device or pharmaceutical industry.
* Advanced knowledge of Medical Device Regulation (MDR).
* Fluent English (C1 level)
* Immediate Availability
* Trustful, Stress tolerant, Goal oriented & Social
#J-18808-Ljbffr