Overview: The Regulatory Affairs Manager is responsible for leading regulatory functions and serves as management..., supervise, and provide direction in the following areas: Regulatory Strategy, Product Registration and Market Clearance, Device...
following areas: Regulatory Strategy, Product Registration and Market Clearance, Device History Record Review, Employee Training... for Regulatory Compliance (PRRC) according to Article 15 of EU MDR 2017/745. Serve as lead contact for inspections by regulatory...
&D, engineering, and regional teams with regards to compliance, enforcement, remediation, and regulatory compliance affairs Maintain... will be part of the Hardware Regulatory Compliance Team, responsible for surveillance and compliance management of Stratasys' wide...