Weinheim, Baden-Württemberg, Germany
Person Responsible for Regulatory Compliance for Leica Biosystems Nussloch GmbH in accordance with the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 - article 15. Key Responsibilities: • Ensure the post-market surveillance obligations in Articles 10(9) and 78 (IVDR) are complied with; • All vigilance reporting obligations referenced in Articles 82 to 86 (IVDR) are fulfilled; Additional Responsibilities include: - Acting as Internal Auditor - Approval of Marketing/MAPSS Materials - Complaint Handling - Reporting of MDRs - Management of FSCAs/Recalls - Communication with Regulatory Authorities - MHRA/MORE Organisation Lead (Manufacturer) - Review and Approval of Post-market Surveillance Activities - Review of applicable Standards and Regulations - CAPA Approver - Co-lead and support of Notified Body Audits
- Internal Auditor - Approval of Marketing/MAPSS Materials - Complaint Handling - MDRs/Vigilance - Management of Field Actions/Recalls - Communication with Regulatory Authorities - MHRA/MORE Organisation Lead (Manufacturer) - Review and Approval of Post-market Surveillance Activities - Review of applicable Standards and Regulations - CAPA Approver
- Non-Conformity Officer of the Medical & Scientific Affairs department - CAPA/Change Officer of the Medical & Scientific Affairs department - Confirming and documenting the scientific validity of IVDs - Analytical and clinical performance evaluation of Legacy IVDs, as well as IVDs under development, according the (EU)2017:746 In-vitro Medical Devices Regulation (IVDR) - Planning and documenting post-market performance follow-up (PMPF) activities of IVDs currently placed on the EU market - Proactive coordination with other departments as well as external partners to ensure the safety and performance of our IVDs according to the application of risk management to medical devices (ISO 14971:2020) while working in a medical devices - quality management system (ISO 13485:2016) regulated environment. - Working in a deadline-oriented manner within a project management guided framework
- Laboratory Safety Officer responsible for monitoring work carried out with biological and radiological samples. - Accurate and efficient planning, execution and documentation of my own scientific experiments and procedures. - Successful completion of several results-oriented scientific projects and their publication in renowned scientific journals. - Competent communication of scientific results to colleagues and the wider scientific community. - Taking part in the supervision of visiting students and their projects