Zuzana Holková

Ensure regulatory compliance of medical devices in accordance with applicable regulations and national requirements. Coordinate and prepare regulatory/clinical product notifications and registrations within established timelines. Register new medical products and update existing registrations to ensure lifecycle compliance. Support customers with product registrations in international markets. Communicate with National Competent Authorities and Notified Bodies. Ensure that all written deliverables conform to international standards and relevant regulatory guidelines. Prepare responses to customer inquiries, including product data requests, regulatory statements, surveys, and questionnaires. Create and maintain Technical Documentation and regulatory files (e.g., Instructions for Use (IFU), Declarations of Conformity, summary reports, Bill of Materials). Prepare and maintain Clinical Evaluation documentation, including Device Descriptions, Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and Literature Search protocols/reports. Manage Post Market Clinical Follow-up (PMCF) activities and survey projects. Support cross-functional teams (Purchasing, Marketing, Engineering) and suppliers regarding regulatory compliance. Review product promotional materials, labeling, batch records, specification sheets, and test methods to ensure compliance with applicable regulations and policies.

Pharmacovigilance (PV) & Regulatory Affairs (RA) Responsibilities: Act as the Local Responsible Person for Pharmacovigilance (RPP). Serve as the primary point of contact for National Competent Authorities. Support the creation and maintenance of the Pharmacovigilance System Master File (PSMF), including regular updates of Annexes. Create, review, and update local Standard Operating Procedures (SOPs) to ensure compliance. Manage additional Risk Minimisation Measures (aRMMs). Support and participate in PV inspections and audits. Perform weekly monitoring of authority websites and databases. Prepare Reference Safety Information (RSI). Prepare Safety variations (full packages) in compliance with PSUSA / MHRA requirements. Maintain medicinal product information and documentation (e.g., SmPC, PIL) throughout the product lifecycle. Conduct and ensure global and local literature searches. Prepare monthly compliance reports. Good Distribution Practice (GDP) Responsibilities: Act as the Responsible Person for GDP for the EU distributor (Indoco Remedies Czech), ensuring compliance with EU GDP Guidelines.