Technical Study Manager (m/w/d) / Manager Technische Studien (m/w/d)
Core
Lead scientific planning, execution, and reporting of regulatory Extractables & Leachables (E&L) and chemical characterization studies for medical devices per ISO 10993-18.
Role type
Senior Study Manager (Regulatory Science)
Builds
Regulatory-compliant study reports and analytical data packages for medical device clients
Domain
Medical Devices / Regulatory Science / Analytical Chemistry
Required skills
Study planning and execution, Regulatory compliance (ISO 10993-18, ISO 17025), Analytical data interpretation, Client consultation, Project management, Cross-functional team leadership, Technical problem solving
Preferred skills
GC-MS, LC-MS, ICP-MS, Analytical laboratory experience, Customer service experience
Technologies
GC-MS, LC-MS, ICP-MS, Microsoft Office
Responsibilities
Oversee E&L and chemical characterization studies from start to finish, Create and approve study plans and scientific reports, Analyze and interpret analytical data, Advise clients on study design and timelines, Manage interfaces with auditors, inspectors, and subcontractors, Coordinate interdisciplinary teams
Seniority
Senior, hands-on IC
