Looking for Regulatory Manager for Medical Devices (Munich)
Dear all, my company has a oppening for a very challenging position in Saudi Arabia. Here some information:
TÜV SÜD is operative as Conformity Assessment Body (CAB) in Saudi Arabia. The CAB is responsible to review the “Medical Device Marketing Authorization” applications. The applications are reviewed in accordance with the Medical Devices Interim Regulations.
The regulatory manager is responsible for the operation of the reviews. This includes the technical co-operation with the European headquarter, experts outside KSA and the management of local staff.
Further he is responsible for the development of the CAB unit quality plan and to ensure that the required procedures are in line with regulatory requirements.
Candidates should have the following knowledge on International Regulatory Requirements:
• Mandatory: European Medical Device Directive, MDD
• Preferable: US-FDA (PMA, Protected content , QSR), Canadian Medical Device Regulations, CMDR,
• Japan's Pharmaceutical Affairs Law, JPAL
• Nationality: European
• Qualification: Bachelor or Master Degree in engineering / science / medicine
• Experience: A proven track record or demonstrable experience in the field of standard, regulatory, legislative for Medical Devices.
• Experience in operations management of a service organization
• Skills: Good communication skills in English. Knowing Arabic will be an advantage.
Feel free to conatct me if you got intersted in the position