Regulatory Affairs Project Manager - Ballaigues, Switzerland or Munich, Germany
Dentsply Sirona
Switzerland, Europe
vor 7 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 our new Regulatory Affairs Project Manager, you will not only manage our Risk Management files and technical documentation, but you will also champion these files during audits and authority inspections.

Using your expertise, you will ensure that our documentation is up-to-date and compliant with all current regulations, and you will also make a valuable contribution in continuous improvement processes and projects.

MAIN RESPONSIBILITIES

  • Manage update and maintenance of 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 documentation
  • 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 documentation of the SBU, in the context of the company re-organization
  • Ensure compliance with applicable and accurate standards and our SOPs
  • Perform technical documentation 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 in providing technical answers to Health Authorities where needed
  • 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 English (native or C1); French or German would be a strong 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
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