Global Clinical Research Specialist -- Ballaigues, Switzerland or Munich, Germany
Dentsply Sirona
Switzerland, Europe
vor 16 Tg.

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.

As The Dental Solutions CompanyTM, Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better, safer and faster dentistry.

Dentsply Sirona’s global headquarters is located in York, Pennsylvania, and the international headquarters is based in Salzburg, Austria.

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

MAIN RESPONSIBILITIES

  • Drive Clinical Compliance documents for development and registration of medical devices
  • Implement, review and interpret safety and efficacy clinical evidence to create and update Clinical Evaluation Dossiers in accordance with NF EN ISO 14155 : 2012, MEDDEV.
  • 2.7.1 Rev4, MDD (93 / 42 / EEC), MDR (2017 / 745)

  • Prepare and / or provide input to Post Market surveillance and Post Market Clinical follow-up
  • Perform biological safety assessment for new products in development as well as for marketed products
  • Serve as clinical expert in communications with regulatory authorities worldwide.
  • Implement and manage pre-and post-market scientific in vitro and ex vivo studies
  • Act as clinical science expert for management of sponsored clinical studies (phase I- IV) as well as Investigator initiated studies
  • Represent Clinical Affairs (clinical science expert) in cross-functional projects / meetings
  • Provide clinical scientific input to business development and marketing activities (i.e. scientific communication, literature review, data interpretation)
  • Act as clinical science expert liaison to consultants, country teams and others
  • Establish relationship with investigators, dentists, KOLs and partners
  • PROFILE

  • Masters’ or PhD in science, biological science, engineering, or equivalent
  • Minimum 3 years’ international experience in Clinical Research, Regulatory Affairs, or Clinical Affairs
  • Advanced knowledge of medical devices regulations, i.e. ISO norms 13485 and 10993-1 MEDDEV. 2.7.1 Rev 3 and 4, European and US Medical Devices regulatory requirements (MDD, FDA, 21 CRF).
  • Knowledge of GCP, clinical trial regulation (ICH-GCP), design and management, statistical analysis methodology and regulatory / clinical development process is a plus
  • Demonstrated ability to establish strong scientific partnership with key stakeholders
  • Excellent communication skills (written and oral) in English (B2 min) and French (B2 min), German would be a plus
  • Solid skills in MS Office + MS Project or equivalent, as well as scientific databases for literature search
  • Strong diplomatic and interpersonal skills with a team focus
  • Excellent analytic skills
  • Proactive, result-oriented nature
  • Customer-orientation
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