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Technical File Project Manager - Ballaigues, Vaud

Dentsply Sirona

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Technical File Project Manager - Ballaigues, Vaud

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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. This position will be located in Ballaigues, Switzerland.



MISSION

As our new Technical File Project Manager, you will be responsible for all technical files in Dentsply Sirona's Strategic Business Unit (SBU) of Endodontics. You will ensure that our Risk Management files and technical documentation are up-to-date and compliant with all current requirements, and you will champion these files during audits and authority inspections. You will also make a valuable contribution in continuous improvement processes and projects.

MAIN RESPONSIBILITIES

  • Coordinate update and maintenance of the legacy technical documentation. Propose and implement actions following GAP analysis with respect to MDD and MDR
  • Coordinate cross-functional activities regarding technical documentation (i.e. with R&D, Clinical Affairs)
  • Manage project team to update all technical files in the framework of MDR implementation
  • Prepare and manage product risk management meetings
  • Ensure implementation of all required actions to update technical files
  • Ensure clinical risks identified in process risk analysis are duly reported into the product risk analysis
  • Ensure consistency between all risk management files
  • Merge all the technical files of the SBU, in the context of the company re-organization
  • Ensure compliance with applicable and accurate standards and our SOPs
  • Perform technical file and risk management assessments during a change control
  • Provide support to Clinical Affairs and R&D in the creation of biocompatibility and usability studies
  • Manage sub-projects, together with R&D and QA, to improve the technical file management process (i.e. change control, process risk management, device master record)
  • Support the complaints department to provide technical answer to Health Authorities
  • Ensure the information contained in department databases is up-to-date

PROFILE

  • Bachelors' or Masters' degree in Biomedical Engineering, Life Sciences, or equivalent
  • 5 years' experience in technical file management in an international MedTech environment
  • Strong background in Risk Management (EN ISO 14971), Usability Engineering (EN 62366), Biological Safety (ISO 10993-x)
  • Solid knowledge of the European Medical Device Directive and European Medical Device Regulations
  • Excellent communication skills in French (native or C1), English (native or C1); German skills a plus
  • Good skills in MS PackOffice and an ERP (preferably AX Dynamics)
  • Excellent team player with a strong customer-orientation
  • Strong planning and project management skills
  • Solid problem-solving and decision-making skills; ability to summarize complex information effectively
  • Flexibility, perseverance, rigor and a methodical nature


                                                                                                                                      



 

Ch. du Verger 3 1338 Ballaigues