Senior Analytical Lead — Medical Device Testing & Regulatory

SimplyVision GmbH; Basel; Hybrid; CHF 110,000 - 140,000; Full time

Benefits offered by this job

Swiss payroll possible

Job summary

SimplyVision GmbH in Basel, Switzerland, seeks an Analytical Expert Service within Medical Device Activities (m/f/x) for freelance engagement or CH payroll, starting 01.01.2027 and ending 31.12.2027. The role covers analytical activities for device testing and method transfer, with responsibility for coordinating internal and external labs.

You will oversee outsourced projects, contribute to regulatory documents, and support inspections using statistical tools (e.g., Minitab).

Qualifications

• Expertise in ISO norms, Ph. Eur. and USP and their interpretation.
• Analytical methods development and transfer to labs.
• Statistical analysis using software such as Minitab.
• Strong coordination across device and drug product teams.

Responsibilities

• Serve as single point of contact for analytical activities within the project.
• Create project-specific analytical methods and transfer to internal/external labs.
• Select testing laboratories aligned with resources and strategy for projects.
• Lead outsourced analytical activities and manage external partnerships.
• Contribute to regulatory documents and support inspections.
• Apply statistical analysis with tools like Minitab.
• Oversee and lead all analytical activities for assigned projects.

Skills

ISO/Ph Eur/USP expertise

Analytical methods application

Statistical data analysis

Cross-functional coordination

Minitab proficiency

Tools

Minitab

NRV

GLIMS

1-QEM

Job description

SimplyVision GmbH in Basel, Switzerland, seeks an Analytical Expert Service within Medical Device Activities (m/f/x) for freelance engagement or CH payroll, starting 01.01.2027 and ending 31.12.2027. The role covers analytical activities for device testing and method transfer, with responsibility for coordinating internal and external labs.

You will oversee outsourced projects, contribute to regulatory documents, and support inspections using statistical tools (e.g., Minitab).