Expert Regulatory Documentation Medical Devices/IVDs (all genders)

Expert Regulatory Documentation Medical Devices/IVDs (all genders) 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 Englishand Germanskills

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.

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

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