About Straumann

Headquartered in Basel, Straumann is a global leader in implant and restorative dentistry and oral tissue regeneration. Having pioneered many of the most influential technologies and tech-niques in our field, we have a tradition of doing more to advance dental regeneration, restora-tion and replacement, as well as patient care. Straumann partners with passionate people who fit in with the agile dynamics of our size-for-success company. People at Straumann appreciate the opportunity to shape our future and create impact. Encouraging leadership and inspiring ideas from our people has guided us through our proud history of pioneering innovations.

About The Role

Reporting directly to the Quality Manager, the main tasks assigned for the position are:

• Working in the Quality Assurance - Regulatory Affairs Department, helping to maintain and improve the integrated and MDR compliant QMS.
• Implement new Regulations/Standards in the QMS.
• Maintain up to date regulatory compliance for each geographical area.
• Involve in all processes, review, prepare and maintain related procedures.
• Prepare technical documentation following EU regulatory requirements.
• Implement harmonised standards.
• Provide development and support to achieve departmental objectives.
• Be proactive in identifying opportunities for improvement in the QA/RA department.
• Collaborate in planning and problem solving procedures to ensure continuous improvement in the QA/RA department.
• Internal audits: perform product and process audits to ensure compliance with standards.
• Work cooperatively with subcontractors on new technical and customer requirements, including audits and monitoring of their QMS procedures.
• Collaborate with other departments to ensure that QMS requirements are deployed in accordance with the PLM.
• Perform Post Market Surveillance (PMS), Post Market Clinical Follow-up (PMCF), Clinical Evaluation of medical devices in accordance with the MDR and clinical database management.
  
  

Desirable competences

• Knowledge of MDR and ISO 13485
• Initiative
• Interest in innovation
• Ability to teach and transfer knowledge
• Ability to become technically proficient in the assigned area
• Ability to obtain and analyse information
• Creative thinking
• Ability to synthesise
• Languages: English level B1 or higher
  
  

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