Position: Project Manager - Risk Manager
Role Type: Permanent
Role Overview
We are supporting a Leading Biotech in the Lausanne region develop their Quality/Risk Management team. Having experienced extensive investment, the Quality team is seeking global expansion; Lausanne, Boston and the Bayonne region.
The role will implement new risk assessment procedures for their innovative data-driven medicine platform and medical imaging.
Responsibilities
- Design, review and coordinate Risk Assessment dossiers
- Responsible for customer complaint management
- Quality System conformity and implementation
- Plan external audits
- Oversee Quality Assurance Team day to day tasks/KPIs
- Forecast and plan future projects for the business
- Regular interaction with Senior Quality Management team
Essential Criteria
- Successfully completed Scientific or Engineering degree (BSc/Msc)
- Knowledge of working under and/or implementing systems related to MDR (2017/745), DIN EN ISO 13485, DIN EN ISO 14971, FDA QSR 21CFR820
- Experience in designing Medical Product
- Internal/External Audit experience required
- Software experience (DIN EN ISO 62304)
- IT Security risk management experience (DIN EN ISO 27001)
- Fluent English
Benefits
- Becoming a key figure in a globally leading Biotech organisation
- Industry leading Biotech portfolio
- Globally expanding company
- Industry leading training scheme
