Katalyst CRO
Overview
Regulatory Affairs Associate at Katalyst CRO. Supports international addendum labelling (IFUs, import labels, and country-specific labeling) for medical devices. Collaborates with global RA teams and owns labeling compliance processes. Responsibilities
Develop and design compliant labeling, including IFUs and international labels. Coordinate cross-functional teams and manage multiple labeling projects. Implement changes per international regulatory guidelines. Fill out forms, review redlines and submit packages to the labeling team. Track labeling change requests and maintain documentation for audits. Monitor global regulatory trends and update internal procedures. Support quality system improvements and KPI reporting. Requirements
Bachelor\'s degree in Regulatory Affairs, Biomedical Engineering, or related field. 4+ years in regulatory/quality operations within a regulated industry. Experience with labeling design, document control, and regulatory submissions. Strong knowledge of FDA and international device labeling regulations. Proficiency in SAP, Adobe Acrobat, and MS Office. Experience with Class III implantable medical devices. Hands-on with PMA supplements, change assessments, and audit preparation. Strong project coordination and stakeholder communication skills.
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Regulatory Affairs Associate at Katalyst CRO. Supports international addendum labelling (IFUs, import labels, and country-specific labeling) for medical devices. Collaborates with global RA teams and owns labeling compliance processes. Responsibilities
Develop and design compliant labeling, including IFUs and international labels. Coordinate cross-functional teams and manage multiple labeling projects. Implement changes per international regulatory guidelines. Fill out forms, review redlines and submit packages to the labeling team. Track labeling change requests and maintain documentation for audits. Monitor global regulatory trends and update internal procedures. Support quality system improvements and KPI reporting. Requirements
Bachelor\'s degree in Regulatory Affairs, Biomedical Engineering, or related field. 4+ years in regulatory/quality operations within a regulated industry. Experience with labeling design, document control, and regulatory submissions. Strong knowledge of FDA and international device labeling regulations. Proficiency in SAP, Adobe Acrobat, and MS Office. Experience with Class III implantable medical devices. Hands-on with PMA supplements, change assessments, and audit preparation. Strong project coordination and stakeholder communication skills.
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