Manager Material Compliance And Regulatory Affairs
CurrentRegulatory Affairs-Preparation and mainenance of Statements and declarations of conformity-Communication with authorities, distributors, HEINE Customer Service and Area Sales Manager-Preparing relevant documents for approvals worldwide, specifically Japan and India-Preparation of technical documents such as risk management, statements, clinical evlaluations, PMS and PMCF-Supervision of external tests with regard to biocompatibility-Creation and maintenance of process descriptions-Answering customer queries via ticket system-Working with ERP system Navision-Advising other departments on regulatory issues-Monitoring and researching regulatory requirementsMaterial Compliance-Material Compliance Coordinator at HEINE-Maintenance of continuous material compliance requirements management like REACH, RoHS, California Proposition 65, POP-Prepare and maintain compliance documentation, reports, and certifications to meet regulatory requirements and support audits-Carrying out the material compliance assessment for products and commissioning materials testing-Collect and analyze data on the chemical composition of materials-Obtain and review supplier declarations to verify the compliance of sourced materials-Manage compliance databases and software tools that track and store material compliance information-Work closely with procurement, engineering, quality assurance, and legal teams to integrate compliance requirements into product design and sourcing processes-Educate and inform internal teams and suppliers about compliance requirements and changes in regulations-Provide compliance information and support to customers, including responding to inquiries about material content and regulatory adherence
