Analytical Expert, Medical Device Testing & Method Transfer

Aequor Consulting GmbH; Basel; On-site; CHF 110,000 - 170,000; Full time

Benefits offered by this job

Vacationary leave

LinkedIn Learning access

Certifications funding

Reka Card contribution

Fitness contribution

Job summary

Aequor Consulting GmbH in Basel seeks an experienced Analytical Expert to lead analytical activities across medical device projects. You will drive method development, transfers, and statistical analyses while coordinating with internal teams and external laboratories.

The role involves regulatory documentation support, project registrations, and participation in inspections. Strong English communication and knowledge of ISO/Ph. Eur./USP are essential.

Qualifications

• Extensive expertise in ISO standards, Ph. Eur. and USP interpretations.
• Strong expertise in analytical mechanical testing methods for medical devices.
• Proven experience in analytical method development and transfers to internal and external labs.
• In-depth knowledge of statistical data analysis and proficiency with statistical software (Minitab).
• Excellent coordination and communication with cross-functional teams and external labs.
• Experience coordinating outsourced analytical activities and regulatory documentation.

Responsibilities

• Act as the single point of contact for analytical activities related to medical device testing within projects.
• Oversee and lead analytical activities across projects, ensuring alignment with objectives and customer requirements.
• Develop project-specific analytical methods and transfer them to internal and external laboratories.
• Select testing laboratories based on resources and capabilities; define insourcing vs outsourcing strategy.
• Lead outsourced analytical activities at external labs and manage partnerships across two projects.
• Coordinate analytical activities with cross-functional device project teams and stakeholders at drug product level.
• Support regulatory documentation preparation and project registrations.
• Assist regulatory inspections and present analytical activities and documentation.
• Conduct and oversee statistical data analysis to support decision-making.

Skills

Statistical data analysis

Analytical method development

Method transfer to labs

Minitab

Coordination & communication

ISO standards interpretation

Tools

Minitab

Job description

Aequor Consulting GmbH in Basel seeks an experienced Analytical Expert to lead analytical activities across medical device projects. You will drive method development, transfers, and statistical analyses while coordinating with internal teams and external laboratories.

The role involves regulatory documentation support, project registrations, and participation in inspections. Strong English communication and knowledge of ISO/Ph. Eur./USP are essential.