Regulatory Affairs Specialist (m/w/d)
Core
Identify and translate regulatory, normative, and technical developments into actionable requirements for precision positioning and measurement systems in the Life Science & Light Microscopy sector.
Role type
Regulatory Affairs Specialist
Builds
Precision components and systems for exact positioning and measuring in the micro- and nanometer range
Domain
Life Science & Light Microscopy / Medical Devices
Required skills
Regulatory compliance knowledge, Technical documentation, Risk analysis (FMEA, Control-Plan), Quality management system adaptation, Cross-functional consultation, Process design
Preferred skills
German (C1), English (C1), Medical device development experience
Technologies
(P)FMEA, Control-Plan
Responsibilities
Monitor and evaluate relevant laws, regulations, standards, and market developments; Derive concrete action recommendations and support product development in implementing regulatory requirements; Translate regulatory provisions into verifiable development specifications and acceptance criteria; Identify and support necessary adjustments in the quality management system; Prepare and moderate product and process risk analyses; Consult sales and technical departments on regulatory products and market access; Support customer and supplier discussions.
Seniority
Mid-level, hands-on IC