director of quality and regulatory to c-rad in uppsala

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uppsala, stockholms lan
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Bioteknik och Medicin
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job description

Are you interested in making an impact in the area of radiation therapy and help new products reach the market? Do you want to help patients around the world to get more efficient radiation therapy? C-RAD is looking for their next Director with assignments within quality control, quality assurance and regulatory affairs.

C-RAD works within the field of radiation therapy and are trying to improve among other things real time monitoring of radiation therapy.

Job description
You will implement and maintain Quality Systems for C-Rad global quality and regulatory systems in compliance with US Food and Drug Administration, ICH and international requirements, and will lead the strategic and operational aspects of C-Rad’s quality and regulatory program. You are responsible for the Quality Control and Quality Assurance functions and ensure compliance to corporate policies, US FDA, other applicable federal/state agency and international requirements, as appropriate. You also lead the preparation and submission of regulatory documents in the US and other countries for approval at various stages of the submission process. You will be the contact point towards the FDA, EU and other regulatory agencies.

Other common tasks will be:

- Conducting internal and external audits.

- Manage supplier quality and contract manufacturing quality.

- You will be the global quality representative within the company.

- Provide regulatory training and foster a corporate commitment to quality.

For this role we see a person who has worked within the field of medical or biological devices. You probably have an bachelor’s degree in engineering, science or other relevant field. Have you also had experience with the FDA and been the lead auditor then this job will suit you. In this role we give you the opportunity to work in a wide range of tasks from implementing a quality system to training the employees and assure quality compliance. As a person we see this employee as an:

- Collaborative person that puts the companies goals first.

- Ability to engage colleagues and keep a positive attitude

- Listen attentively to colleagues and other collaboration partners.

There will be travels less than 20 % of the time. It is important for us to see that all of the competencies in the market. We welcome all candidates.

Application: Please apply before 2019-04-24. In this recruitment selection will take place continuously. Please send in your application today!

Contact information: In this recruitment C-RAD has decided to collaborate with Dfind Science & Engineering. Please contact Jenny Davidsson for any questions concerning this position.