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Global Clinical Research Specialist - Ballaigues, Switzerland

Inseriert am: 16.01.2020







 

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

 

Bringing out the best in people

As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.

 

Working at Dentsply Sirona you are able to:

 

Develop faster - with our commitment to the best professional development.

 

Perform better - as part of a high-performance, empowering culture.

 

Shape an industry - with a market leader that continues to drive innovation.

 

Make a difference -by helping improve oral health worldwide. 

 


MISSION


As Global Clinical Research Specialist in our Clinical Research group, you will provide technical and scientific expertise to our Clinical Affairs, R&D, Quality, Sales, Marketing and Manufacturing departments for the development and commercialization of medical devices.


 


 


MAIN RESPONSIBLITIES



  • Create and update Clinical Evaluation dossiers for new medical devices and already marketed products in accordance with NF EN ISO 14155:2012, MEDDEV.2.7.1, MDD (93/42/EEC), MDR (2017/745), as well as Post Market surveillance data

  • Represent Clinical Research in project teams for new product development

  • Implement / manage research studies

  • Manage / implement pre- and post-market sponsored clinical studies (phase I- IV) as well as investigator-initiated studies, including communication with university groups, Key Opinion Leader Management, writing of Clinical Investigation Plan, IB, CRF, etc.

  • Create and update clinical documents for launched product support, including performing literature searches, data interpretation and creation of scientific communication documents

  • Perform biological safety assessments for new products in development and marketed products

  • Support in the creation and review of technical files

  • Support in the review of documentation (labelling)


 


 


PROFILE



  • Masters or PhD in science, biological science, medicine, or equivalent

  • Minimum 3 years’ relevant professional experience with medical devices in an international environment

  • Very good knowledge of ISO 13485, Guide MEDDEV. 2.7.1 4, good knowledge of ISO 10993-1, as well as European Regulatory rules (MDD) and US (21 CRF) concerning medical devices, FDA

  • Good knowledge of Clinical search best practices concerning medical devices and related statistics, ICH (Guideline for Clinical Trial)

  • Very good knowledge of MS Office + ERP (i.e. MS Project)

  • Excellent communication skills in French (B2/C1) and English (B2/C1); German is a plus

  • Strong skills in writing scientific and technical documentation

  • Good knowledge of scientific databases for documents research

  • Proactive, cooperative attitude

  • High analytical skills

  • Service- and customer-orientation

  • Ability to work autonomously

  • Very good organizational and planning skills


 


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