Expert Regulatory Documentation Medical Devices/IVDs (all genders)

Greiner Bio-One International; Schürzendorf; Presencial; EUR 55 000 - 67 000; Tempo integral

Resumo da oferta

Greiner Bio-One International sucht eine erfahrene Fachkraft im Bereich Studien-Submission-Management, die Einreichungen bei Ethikkommissionen und Behörden in Österreich koordiniert. Sie steuern TMF-und Studiendokumentation, verwalten die Studien-Datenbank und arbeiten eng mit internen wie externen Stakeholdern zusammen.

Zu den Aufgaben gehört die Sicherstellung der Audit-Readiness, Unterstützung regulatorischerInspektionen sowie die Einhaltung nationaler Vorschriften in Europa.

Qualificações

• Abgeschlossenes naturwissenschaftliches Studium oder gleichwertige Qualifikation.
• Erfahrung in klinischen Studien oder IVD-/MD-Studien ist wünschenswert.
• Gute Koordinations- und Organisationsfähigkeiten, strukturiertes Arbeiten.

Responsabilidades

• Vorbereiten, Zusammenstellen und Einreichen von Unterlagen bei Ethikkommissionen und Behörden.
• Verwalten von initialen Einreichungen, Änderungen, Jahresberichten und Abschlussberichten.
• Koordination der Einreichungs-Dokumente von Fachbereichen und Standorten.
• Hauptansprechpartner für Ethikkommissionen und Behörden zu Studien-Einreichungen.
• Überwachung von Fristen und regulatorischen Meilensteinen.

Conhecimentos

Deutsch

Englisch

Formação académica

Universitätsabschluss in Lebenswissenschaften

Descrição da oferta de emprego

Your challenge

• Prepare, compile, and process submissions to Ethics Committees (ECs) and Competent Authorities (CAs) for MD clinical investigations and IVD performance studies.
• Manage initial submissions, amendments, annual reports, notifications, and end-of-study submissions.
• Coordinate the collection of submission documents from cross-functional stakeholders.
• Act as the primary contact for Ethics Committees and Competent Authorities regarding study submissions.
• Track submission timelines and ensure timely completion of regulatory milestones.
• Support country-specific submission strategies and regulatory pathways.
• Coordinate responses to authority and ethics committee requests, questions, and deficiency letters.
• Monitor applicable regulatory requirements and support continuous process improvements

Study Submission Management

• Prepare, compile, and process submissions to Ethics Committees (ECs) and Competent Authorities (CAs) for MD clinical investigations and IVD performance studies.
• Manage initial submissions, amendments, annual reports, notifications, and end-of-study submissions.
• Coordinate the collection of submission documents from cross-functional stakeholders.
• Act as the primary contact for Ethics Committees and Competent Authorities regarding study submissions.
• Track submission timelines and ensure timely completion of regulatory milestones.
• Support country-specific submission strategies and regulatory pathways.
• Coordinate responses to authority and ethics committee requests, questions, and deficiency letters.
• Monitor applicable regulatory requirements and support continuous process improvements

Study Documentation & TMF Management

• Maintain GBO specific Document filing system for studies and study‑specific TMF structures.
• Ensure timely filing of mainly submission documentation packages
• Support maintenance of TMF inspection readiness throughout the study lifecycle.
• Support document version control and management of essential study documentation
• Support internal audits, external audits, and regulatory inspections.

Study Information Database Management

• Establish, maintain, and continuously improve a centralized, searchable database for closed MD and IVD studies.
• Ensure structured capture and maintenance of key study information, including study objectives, products, study designs, countries, participating sites, regulatory approvals, study outcomes, and final study documentation.
• Define and maintain searchable metadata and indexing to enable efficient retrieval of historical study information and documents.
• Generate study overviews, reports, and summaries to support regulatory, clinical, quality, and business functions.
• Support cross‑functional stakeholders by providing access to historical study information and archived study records for regulatory submissions, clinical evaluations, performance evaluations, audits, inspections, and other business needs.
• Ensure completeness, accuracy, consistency, and long‑term accessibility of study records and associated metadata.
• Identify and implement opportunities for continuous improvement of study information management processes and tools.

Your profile

• University degree in life sciences or an equivalent combination of education, training and work experience in clinical trials
• Minimum 3-5 years of experience in clinical trials, preferred MD or IVD, as start up specialist, TMF manager, submission specialist, clinical trial assistant
• Experience in setting up and maintaining a study Information Database is considered advantageous strong asset
• Experience of submission in various European countries is considered a strong asset
• Experience of submission of IVD and MD studies a strong asset
• Familiarity with EUDAMED is considered advantageous
• Effective and appropriate verbal and written communication with internal and external stakeholders, locally and globally
• Ability to organize tasks, time, and priorities, ability to multi-task
• Proficient English and German skills
• Willingness to travel to our locations in Austria is required

Our offer

We offer you an exciting and independent area of responsibility in a modern and collegial working environment. In addition to numerous attractive social benefits, the gross annual salary for this position is at least EUR 60.977,70 (minimum salary according to the collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment.

Wir bieten gleiche Chancen für alle und sehen Vielfalt als unsere Stärke. Daher begrüßen wir Bewerbungen von allen Menschen – unabhängig von Merkmalen wie Geschlecht, Alter, Hintergrund, sozialem Status, sexueller Orientierung, Religion sowie geistigen und körperlichen Fähigkeiten. Es ist unser Ziel, Frauen im Unternehmen zu stärken und den Anteil an weiblichen Führungskräften zu erhöhen. Wir fördern eine inklusive Arbeitsumgebung und ermutigen alle Personen, sich zu bewerben.