Description

I work with medical device manufacturers preparing for CE marking, responding to notified body deficiencies, or remediating legacy clinical evaluation files under the MDR. The files I deliver are built for the reviewer on the other side of the submission: internally consistent, evidence-anchored, and structured to survive NB scrutiny.

Clinical Evaluation Plans and Reports (CEP / CER)

Authoring aligned to MDR and MDCG guidance:

Scope, intended purpose and equivalence framing
Clinical evidence identification and appraisal
Safety and performance acceptance criteria set against the state of the art
Clinical data gap analysis
Benefit–risk conclusions consistent with the risk management file and IFU

Systematic literature search

Defensible search strategies for state of the art, safety and performance - with transparent screening, appraisal, and PRISMA-grade documentation. The version that holds up when the notified body asks how a study was included or excluded.

Post-Market Surveillance and Clinical Follow-up (PMS / PMCF)

Plans and reports that close the loop between real-world evidence and the CER:

PMCF plans and study design where required
PMS data analysis and PSUR/PMS report authoring
Integration of post-market findings back into the CER and risk management file

Industry field of expertise

Languages

German
Native or bilingual
English
Fluent

Workplace preferences

Remote only

Primarily works remotely

Croma-Pharma GmbH,
Regulatory Affairs & Medical Writing Manager
October 2022 - Today (3 years and 10 months)
Austria
Subject matter expert responsible for authoring regulatory documentation for EU and international submissions. Editor, Reviewer, Approver of medical device design control documents spanning from RnD to market launch.
MDR 2017/745 Wissenschaftliches Schreiben Strategische Planning
Platomics GmbH,
Performance Evaluation Manager & Regulatory Affairs Manager
September 2021 - August 2022 (11 months)
Vienna, Austria
Generation, editing, review and maintenance of documents related to safety and performance evaluation of in vitro diagnostic medical devices.
Children's Cancer Research Institute,
Clinical Trial Project Manager
November 2020 - August 2021 (9 months)
Vienna, Austria
Lead and overseeing the planning, execution, and close-out of an international clinical trial.
Coordination of internal and external stakeholders (CROs, investigational sites, investigators, vendors, Authorities, Ethics Committees)
Providing trial master file – US FDA inspection readiness