Raphael Bünter Email & Phone Number

Schlieren, Zürich, Schweiz

Winterthur Und Umgebung, Schweiz

In this position I was responsible to:- support the EU MDR implementation project- create internal regulatory affairs guidelines, trainings, presentations- conduct workshops for internal departments (e.g. labelling compliance)- provide regulatory support for Zimmer Biomet products- support the Winterthur Business Unit in registration dossiers- review internal reports and guidelines

Teufen

As a Product and Quality Manager at SpineworxX AG I was dealing with the following topics:Quality Management and Regulatory- Assistance and substitution of the leading quality manager- Support in setting up a quality management system for the company SpineworxX- Maintenance and adaptation of the quality manual- Assistance for the certification of SpineworxX according to EN ISO 13485:2016- Assistance for the CE certification of the first SpineworxX medical device- Maintenance and preparation of technical documentation- Preparation of the surgical technique and instructions for use Born PT-LIF Cage HA- Implementation of regulatory guidelines, e.g. Directive 93/42/EEC (MDD)- Evaluation of the new Medical Device Regulation (MDR) and preparation for its implementation- Implementation of data security and cloud system- Evaluation and assessment of trademark and legal issues- Implementation of Unique Device Identification (UDI)- Assistance in the development of the product life cycle- Building up the warehouse and responsible for purchasing- Execution of goods receipt and quality control- Structure and monitoring of the measuring equipment inventory- Support of the leading quality manager during external supplier auditsProduct management and marketing- Market evaluation and competitor analysis- Support in product development- Communication and exchange with medical Advisory Board members- Content and style of the company's homepage

Appenzell

As Product Manager of Born Medical AG I was mainly occupied with the following tasks:Marketing activities- Content and style of the company's homepage- Content and style of various marketing materialsSales activities- Support of the sales team at various trade fairs (SGOT, SAfW etc.)- Visits to doctors/patients- wound controls for DermACELL- surgery visitsOther activities- Implementation of data security and cloud system

Zurich

Heilsarmee Brocki HardbrückeAlterszentrum Sydefädeli

Zurich

- Real-time courier planning- Customer service

Zürich Area, Switzerland

Internship & master Thesis: "Sensitivity and accuracy of a self-developed tapping reaction test on a mobile phone”- Planning and designing master thesis study- Ethical protocol- Recruitment of participants- Data collection camera- and pulse oximetry

Magglingen

- Research assistance sensor validation- J+S-Evaluation analysis (SPSS)- assistance in elite-athletes performance tests and monitoring

Master Of Science (Msc), Human Movement Sciences, Sportsphysiology

Scientific studies that aims to communicate knowledge on the human body at the in- terface between medicine and technology

Bachelor Of Science (Bsc), Human Movement Sciences

Solid and fundamental education in natural science (biology, chemistry, mathematics, physics) interdisciplinary thinking in the area.

Matura