Bild

Taking on and mastering new challenges in the development and approval of medical devices over and over again makes my work as a Clinical Evaluation Expert exciting and diverse.


Dr. Tina Richter

CLINICAL & REGULATORY EXPERT


TOP SKILLS: Clinical Affairs - Clinical & Animal Studies, Clinical Evaluation, Data analysis


Why PRO-LIANCE
PRO-LIANCE offers me the opportunity to contribute to the development of medical products from my experience in all areas of clinical research and allows me to support customers in various phases of product development. I am particularly fascinated by innovative medical devices that aim to improve medical care. Patient benefit is the focus of the latest regulatory requirements, which must be implemented in the course of the next years. I want to commit myself to this task without losing the big picture. As a team member of PRO-LIANCE I would like to become part of the complex process, connecting diverse specialist disciplines and achieving its goal of realising marketable products.

Challenges
Together with the experts at PRO-LIANCE and the constantly increasing and diverse qualitative-regulatory requirements, I always want to remain up to date. When preparing clinical evaluations it is thus a matter of producing structured and comprehensible documents that meet all expectations and form the basis for our greatest asset - patient safety.

My strengths
My interest in a wide range of medical fields, my basic training as a biologist and my structured, effective approach form the core of my working methods. In addition, I have a broad variety of professional experience – ranging from the initial product idea to the final review of the clinical evaluation at a notified body.

My motivation
What drives me is constantly developing and increasing my knowledge and experience, without having set an end point, but rather constantly keeping the next step in focus. Setting small goals and appreciating partial successes.

Who I am
As a scientist at heart and a "networker" in my private life, I always enjoy meeting different people and learning from them. Every day I try to manage the balancing act between work and family as well as city life and experiences in nature. Going to restaurants with friends, outdoor activities, travelling to new places and yoga help me to recharge my batteries and face the challenges ahead with a new sense of motivation every day.

Clinical Evaluation Expert

PRO-LIANCE GLOBAL SOLUTIONS GmbH

Expert for Clinical Evaluation (active medical device)

SLG Prüf- und Zertifizierungs GmbH

Clinical Affairs Manager (active medical device)

Sonovum GmbH

Study coordination/ Case management (Early Clinical Trials/ Hematological Oncology)

Universitätsklinikum Leipzig

Clinical Project Manager (IVD)

SelfDiagnostics Deutschland GmbH

Dr. rer. nat. (Immunology)

Scholarship (Virology, Diagnostics)

Universität Leipzig

Internship (Virology)

IISc, Bangalore, India

Clinical Affairs - Clinical & Animal Studies

Clinical Evaluation

Data analysis

Clinical Research Associate (CRA, Pharmaakademie)

Pre-clinical studies

GCP

IVD

Project Management

Quality Management (TÜV)

Risk Management

Systematic literature review

Usability

Languages: German, English