Regulatory Compliance and Risk Manager
This is an outstanding opportunity to join Dentsply Sirona as a Regulatory Compliance and Risk Manager in our digital hub in Zurich. You will be part of a growing organization driving digitalization in the dental industry and located in the vibrant technological and scenic Zurich. As a key member of our QARA team, you will ensure compliance with regulations and standards for our software developments and drive global regulatory strategy. You will oversee regulatory submissions and provide expert guidance to on regulatory topics. Further you will ensure the overarching risk management process. Your role involves close collaboration with global teams within the regulatory, quality, clinical and product/software development departments. This role is a permanent position with 100% capacity in a hybrid work model, that allows you to organize your work and private life as you choose.vThis is an outstanding opportunity to join Dentsply Sirona as a Regulatory Compliance and Risk Manager in our digital hub in Zurich. You will be part of a growing organization driving digitalization in the dental industry and located in the vibrant technological and scenic Zurich. As a key member of our QARA team, you will ensure compliance with regulations and standards for our software developments and drive global regulatory strategy. You will oversee regulatory submissions and provide expert guidance to on regulatory topics. Further you will ensure the overarching risk management process. Your role involves close collaboration with global teams within the regulatory, quality, clinical and product/software development departments. This role is a permanent position with 100% capacity in a hybrid work model, that allows you to organize your work and private life as you choose.
This is an outstanding opportunity to join Dentsply Sirona as a Regulatory Compliance and Risk Manager in our digital hub in Zurich. You will be part of a growing organization driving digitalization in the dental industry and located in the vibrant technological and scenic Zurich. As a key member of our QARA team, you will ensure compliance with regulations and standards for our software developments and drive global regulatory strategy. You will oversee regulatory submissions and provide expert guidance to on regulatory topics. Further you will ensure the overarching risk management process. Your role involves close collaboration with global teams within the regulatory, quality, clinical and product/software development departments. This role is a permanent position with 100% capacity in a hybrid work model, that allows you to organize your work and private life as you choose.
This is an outstanding opportunity to join Dentsply Sirona as a Regulatory Compliance and Risk Manager in our digital hub in Zurich. You will be part of a growing organization driving digitalization in the dental industry and located in the vibrant technological and scenic Zurich. As a key member of our QARA team, you will ensure compliance with regulations and standards for our software developments and drive global regulatory strategy. You will oversee regulatory submissions and provide expert guidance to on regulatory topics. Further you will ensure the overarching risk management process. Your role involves close collaboration with global teams within the regulatory, quality, clinical and product/software development departments. This role is a permanent position with 100% capacity in a hybrid work model, that allows you to organize your work and private life as you choose.
This is an outstanding opportunity to join Dentsply Sirona as a Regulatory Compliance and Risk Manager in our digital hub in Zurich. You will be part of a growing organization driving digitalization in the dental industry and located in the vibrant technological and scenic Zurich. As a key member of our QARA team, you will ensure compliance with regulations and standards for our software developments and drive global regulatory strategy. You will oversee regulatory submissions and provide expert guidance to on regulatory topics. Further you will ensure the overarching risk management process. Your role involves close collaboration with global teams within the regulatory, quality, clinical and product/software development departments. This role is a permanent position with 100% capacity in a hybrid work model, that allows you to organize your work and private life as you choose.
This is an outstanding opportunity to join Dentsply Sirona as a Regulatory Compliance and Risk Manager in our digital hub in Zurich. You will be part of a growing organization driving digitalization in the dental industry and located in the vibrant technological and scenic Zurich. As a key member of our QARA team, you will ensure compliance with regulations and standards for our software developments and drive global regulatory strategy. You will oversee regulatory submissions and provide expert guidance to on regulatory topics. Further you will ensure the overarching risk management process. Your role involves close collaboration with global teams within the regulatory, quality, clinical and product/software development departments. This role is a permanent position with 100% capacity in a hybrid work model, that allows you to organize your work and private life as you choose.
Key Responsibilities:
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- Develop strategies for the global registration of medical device software, considering cloud-based technology applications and the combination of these software applications and devices.
- You will ensure that technical documentation complies with MDR requirements and that the EU declaration of conformity is prepared and kept up to date. You are responsible for the documentation provided to the notified body and relevant authorities
- Serve as the liaison between R & D and regulatory affairs and be the point of contact for local regulatory departments (RA) managing market and regulatory interactions
- You will stay up to date with the ever-increasing global requirements for software as a medical device, building a bridge between the stringent requirements and the goals of the business
- You will assume the responsibility of the overarching risk management process for our SaMD and non-medical SW throughout their lifecycle;
- You will support external and internal audits
- You will act as Deputy PRRC
Requirements:
- Bachelor or advanced degree in Engineering; Life Science or a related field;
- Minimum of 5 years of professional experience in the medical device industry related to the development of software products within this industry
- Sound understanding of MDR and medical (software) device standards and regulations such as ISO13485, ISO 14971, IEC 62304; IEC 62366; IEC 82304, Regulation (EU) 2017/745 (MDR).
- Fluency in English, German is a plus
- Excellent communication skills; strong leadership and interpersonal skills; ability to partner cross-functionally and cross-geographically; ability to operate in and influence a fast-paced environment
Contact
Femke Kok Courant