Karin Listringhaus

// RA- & Quality Mgmt Service for In-Vitro-Diagnostic Manufacturers // RA strategy/RA plan (from R&D through market access); all product classes // Analysis of regulatory compliance acc. to IVDR // Dvlpmt., implementation & maintenance of a QMS (e.g. ISO 13485; 21 CFR 820) // Audit-Mgmt support (w/ authorities/NB, clients, suppliers, internally) acc. to regulatory requirements & -standards // Analysis of organizational structures within RA & QM // Analysis of interface Mgmt & optimization of workflows

Global RA/QM-responsibility across all BIT sites (USA/China/France/Germany). Optimization of processes and procedures across all BIT sites. Assuring regulatory compliance (incl. electrical safety & environmental requirements) during design & development through production acc. to IVDD/IVDR. Audit management (authorities, clients, suppliers, internal); ISO 13485 certification.

RA-Interface Management with clients and across BIT sites. Assuring regulatory compliance acc. to IVDD/IVDR requirements and ISO 13485.

- Leadership (functional and disciplinary in line & matrix). - Functional lead of RA employees/local partners in different countries EU, Non-EU (RU+CIS), LATAM, MENA, ASIA); RA-strategy. - Organizational development & development of employees. - Interface management; Budget-responsibility (dd mio €). - Information officer acc. to § 74a Medicinal Product Act.

Regulatory Department Head and Functional Lead for Molecular Diagnostics (interdisciplinary project teams in multinational context: Life Cycle Management, Design Control Process, RA strategy & submissions, Resources management (RA staff (line&matrix), budget. Manufacturing transfer from Germany to USA acc. to GMP requirements and ISO 13485. Authorized Representative for Roche Molecular Diagnostics.

Authorized representative for Molecular Diagnostics acc. to IVDD; interface to Roche affiliates to assure compliance of submissions to local regulatory requirements in the different countries globally

Design and development of new molecular biological tests through commercial launch; Implementation of Quality System requirements (DIN ISO 9000 ++)

Test development of immunological, histological and cell-biological products for Integrated Health- and Cancer Care Establishment of product specifications and testing methods; tech. transfers to operations competitor analysis

establishing product specifications and testing procedures development of immunoassays (ELISA) preparation and analytic of antigens and antibodies Enzyme Analytik working with carcinogen and infectious material research on cell cultures, cryo-conservation of pro- and eukaryote cells

protein ssequencing, protein analysis (preparative and analytical HPLC, electrophoresis, spectroscopy, photometry) optimization of stabilizing proteins establishing test procedures; production transfer (scale up)

Collection, cultivation, identification and archiving of microorganisms, yeast and fungi optimizing and controlling growing conditions and conservation fermentation

(distance learning while full time working)

(distance learning while full time working)

(learning while full time working)

Clinical chemistry - Histology & Pathology - Hematology - Immunology - Microbiology