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Job Details

Regulatory Affairs Technical File Specialist - Ballaigues, Switzerland or Munich, Germany

Company: Dentsply Sirona
Location: Ballaigues, Switzerland or Munich, Germany
Reference: (57344)
Closing Date: 26 Aug 18
Type: Full Time
Salary (£): Competitive
Benefits: Excellent

Logo: Dentsply Sirona

Job Summary:

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.

Requirements:

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 Technical File Specialist, you will manage actions to upgrade and maintain SBU technical files according the latest regulations and requirements, and you will champion these files during audits and inspections. In this role, you will also closely cooperate with colleagues from R&D and Quality Assurance on projects to improve the Technical File Management Process.

 

MAIN RESPONSIBILITIES

  • Coordinate technical documentation-relates activities within the SBU
  • 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 compliance with applicable internal and external standards and procedures
  • Perform technical file and risk management assessments during change controls
  • Support Clinical Affairs and R&D during completion of biological safety assessments and usability file
  • Make a valuable contribution in sub-projects to improve the technical file management process (change control, process risk management, device master record)
  • Support complaints department to provide technical answer to Health Authorities
  • Update department databases

 

PROFILE

  • Bachelors’ or Masters’ degree in Biomedical Engineering, Life Sciences, or equivalent
  • 1-2 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); German and/or French skills 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

Apply for this job: Regulatory Affairs Technical File Specialist - Ballaigues, Switzerland or Munich, Germany

Contact Information:

Address:  Head Office
Chemin du Verger 3
CH-1338 Ballaigues, Switzerland
Switzerland
Website:  Visit Our Web Site

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