QA / RA Laboratory Coordinator (m/w/d)
Core
Central contact for regulatory affairs on approval-relevant questions and quality officer for the GLP testing facility.
Role type
Senior QA/RA Laboratory Coordinator
Builds
Scientific and medical data packages for regulatory submissions
Domain
Medical device regulation and GLP laboratory testing
Required skills
Regulatory affairs knowledge, GLP monitoring, scientific literature research, process optimization, medical device evaluation
Preferred skills
FDA 21 CFR 820 & 58, MDR, OECD regulations, Agile methods, Lean Management
Technologies
None stated
Responsibilities
Serve as central contact for regulatory affairs on approval-relevant questions, Act as quality officer for the GLP testing facility, Process scientific/medical questions with internal and external experts, Prepare and evaluate scientific and medical data for regulatory procedures, Support pre-clinical evaluations of medical devices, Develop and optimize work processes and instructions
Seniority
Senior, hands-on IC