Freelancer (IVD In vitro diagnostics) Regulatory, Quality Management

- Building up and heading the Marketing and Product Management team (Immune Oncology, POC
tests and ELISA for detecting and monitoring cancer)
- Responsible for Regulatory Affairs and supervising QM personnel and activities
- Defining and controlling of budgets
- Responsible for annual marketing plans and setting up campaigns
- Initiating the introduction of digital QMS tools and realization the transfer in the company
- Reviewing technical documentation for submissions, including the writing and support of
compiling risk management reports according to ISO 14971, IEC 62366
- Writing validation protocols and master validations plans according to CLSI guidelines
- Coordinating market access projects and product launches
- Regulatory responsibilities associated with the development, support and manufacturing of IVD
("others" under the IVDD, class A and C under IVDR), RUO
- Responsible for documentation and coordination needed for monocenter and multicenter
scientific and performance studies and coordinating FDA submissions considering GCP, MPG
and ISO 20916
- Performing internal audits and preparing Management Review meetings

- Strategic development of new business "Clinical Flow Cytometry"
- Defined, recommended and implemented marketing strategies for global and EMEA markets
- Planned and budgeting marketing activities
- Initiated adaptation of organizational processes in SCM and SAP to enable e-commerce for a new
business segment
- Prepared documentation for IFU-capability, labels for upcoming products for research, IVD
diagnostic testing according to guidelines as IVDR, MDR
- Setup performance evaluations for diagnostic products to meet product standards as a

requirement for self-declaration
- Compiled technical files and STED defined by ISO, European, and local guidelines