Claudia Tesch de Oliveira

IFUs, Labels, UDI for medical devices

- Coordinate all IFU-related activities for Zimmer GmbH (e.g. creation, maintenance , process creation). - Provide regulatory input and organize review and implementation of IFUs. - Leading projects and subprojects pertaining IFUs (e.g. e-labelling). - Leading CAPAs pertaining IFU issues. - Support of audits by external parties (Competent authority, Notified Body)

- MDR and MDV Reporting - Writing manuals for MDR and MDV reporting - Updating respective guidelines for PMS - Correspondance with Competent Authorities (e.g. BfarM)

- Support of CE renewal project - Documentation of custom-made devices - Updating guidelines for RA Recon group

- Creating and maintaining the QMS for Nycomed (sales organisation) - Conduct of self-audits and audits of suppliers - GDP-Responsible Person for Nycomed warehouse Singen (pharmaceuticals)

- Writing and reviewing clinical study reports (phase I, phase III) - Writing and reviewing clinical abstracts for publications - Writing and reviewing Investigator Brochures - Setting up clinical trials disclosure project (making clinical studies available on the internet: e.g. clinicaltrials.gov, www.clinicalstudyresults.org)

- Conducting aquatic tests (lab and field) for environmental impact statements - Adherence to GLP requirements

Meeresbiologie Zoologie