Regulatory Compliance Manager 100% - Switzerland
Our company is an internationally leading Medtech global enterprise in the field of heart and lung diagnosis, patient monitoring, defibrillation as well as software solutions for the medical sector. Our products are developed and manufactured in Switzerland and distributed to clinics and practices around the world.
To complete our team in the Regulatory Affairs department, we are looking for a qualified and motivated
Regulatory Compliance Manager
- 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 labeling and marketing documents
- Support regulatory training on CE-marking process
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.