Regulatory Affairs & Product Compliance Specialist (m/w/d)
Core
Ensure products meet regulatory requirements and are internationally compliant, focusing on laboratory equipment and RUO products.
Role type
Regulatory Affairs & Product Compliance Specialist
Builds
Laboratory equipment and RUO products
Domain
Life Sciences / Medical Technology / Regulatory Compliance
Required skills
EU regulations assessment, technical documentation, risk analysis, CE certification, RoHS/REACH compliance, CAPA coordination, regulatory intelligence
Preferred skills
Knowledge of EN 61010-1, EN 61326-1, UL standards, IDVR, product development support
Technologies
CE marking, RoHS, REACH, PPWR, Cyber Resilience Act
Responsibilities
Evaluate EU regulations and standards for lab equipment, prepare conformity declarations, manage technical documentation and risk analyses, conduct conformity assessments and certification procedures, coordinate CAPA cases, support regulatory preparation for new product developments
Seniority
Mid-level, hands-on IC