Beschreibung
Our Client is a provider of laboratory instruments.For an interessting Project, we are looking for a
Project Regulatory / Quality Specialist
Objectives and scope of the job:
- Ensure that the requirements of the new IVD Regulation is implemented in the Quality Management System as well as the technical documentation of the affected Products
Tasks / Activities:
- Supports the IVDR-Project team and work stream leaders to achieve project goals,
- Supports SME’s in assessing gaps in existing QMS and defines required actions and executes accordingly
- Supports SME’s in assessing gaps in existing technical documentation and respective requirements of IVDR
- Defines required actions to close identified gaps and execute accordingly.
- Prepares Training materials relating to IVDR implementation.
- Supports the Quality Team to implement IVDR-requirements in the QMS
- Support Project Lead and Workstream leaders with Project Management tasks
- Act as Project Management Office for IVDR Project
Responsibilities:
- Responsible for the implementation of tasks defined by the Project as required.
- Responsible for the quality of his/ her own work.
Education:;
- Degree in scientific discipline or equivalent Experience
- Good to have : Quality Assurance, process management
- Good to have : RAC certification or other prof. certification
Experience
- Technical Documentation
- Product Development
- Good to have: Risk Management
- Experience in IVDD and GMP environment
- >=3years’ experience in RA
Special Knowledge / Skills
- EC Directives
- IVD-D Knowledge
- IVD-R Knowledge
- Good technical writing skills
Start: at once
Duration: End of 2019
Location: Zürich – East, 100% on Site
Language: English fluent, German nice to have
Application to