Expert Regulatory Documentation Medical Devices/IVDs (all genders)

Dienstgeber: Greiner Bio-One GmbH

Standort: Kremsmünster, Österreich

Stellentyp: unbefristet

Arbeitsform: hybrid

Your challenge

Study Submission Management

• Prepare, compile, and process submissions to Ethics Committees and Competent Authorities 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 and 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 or clinical trial assistant.
• Experience in setting up and maintaining a study information database is considered advantageous.
• Experience of submission in various European countries is considered a strong asset.
• Experience of submission of IVD and MD studies is a strong asset.
• Familiarity with EUDAMED is considered advantageous.
• Effective verbal and written communication with internal and external stakeholders, locally and globally.
• Ability to organize tasks, time, and priorities and to multi-task.
• Proficient English and German skills.
• Willingness to travel to locations in Austria is required.

Our offer

Greiner Bio-One offers 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 according to the collective agreement for the chemical industry. Depending on qualifications and professional experience, a significant overpayment is possible.

If you have any questions or require further information about this job advertisement, please contact Manuela Silbermayr +43 664 8892 0539.