Beschreibung
We are currently searching for a Medical Devices Quality Assurance Manager to be located in Basel on a 12 month contract.
Responsibilities
- Develop, implement, communicate, and maintain global regulatory strategies and plans for high-tech medical devices
- Creating, reviewing, and maintaining regulatory related technical documentation
- Identify and communicate relevant guidance, standards, and regulations
- Part of the team reviewing product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining if regulatory submissions are required
- Working alongside cross-functional teams to obtain relevant information and subsequent review of submission content as needed, assisting with reviews of international product technical documents, marketing, and labelling materials
- Supporting the maintenance of regulatory files and tracking databases
Requirements
- Minimum 3 years of experience in European Medical Device industry and regulatory
- Master's degree in Regulatory Affairs, Engineering or Life Sciences
- Strong knowledge of ISO 13485, ISO 9001, QSR, Council Directive 93/42/EEC and Regulation