SCHILLER AG is an international, renowned medical engineering company, leader in cardiopulmonary diagnostic devices, patient monitoring, defibrillation, emergency care as well as software solutions in the medical sector. Our products are developed and produced in Switzerland and distributed to clinics and medical practices around the world.
To complete our team in the Regulatory Affairs department, we are looking for a qualified and motivated
Regulatory Compliance Manager
Are you interested in joining Regulatory Affairs and would like to take a next step for job rotation? Your main tasks will consist of the following:
Manage and maintain technical documentation acc. to European medical device directive and regulation
Close working with project team and serve as Regulatory Project Manager on guiding projects development including providing regulatory guidance and norm, reviewing technical plan and report, communicating to test lab, etc.
Primary responsible for regulatory compliance prior to device including software release and ensure regulatory control of the ERP-system
Create and revise policy, procedures and work instructions for device release
Coordinating global Regulatory Affairs functional activities to ensure effective support to achieve existing plans and objectives
Involved into change assessment process
Be part of review process for labelling and marketing documents
Support regulatory training on CE-marking process
You have successfully completed your degree in Bio-medical Engineering or equivalent and have at least four years professional experience in Regulatory Affairs of medical device.
Fluent in English and German
Experienced in international medical device environment and familiar with active medical devices
In-depth know-how of technical documentation and CE-conformity assessment
International registration experience including FDA 510(k) and PMA submission experience is a plus
Good organisational and planning skills and due diligence working
Keep up-to-date with the current regulatory environment e.g. medical device regulation
We offer an exciting tailored career path for your professional and personal development within our team. Have we caught your interest? Then please apply online or send your application to: