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Documentation Professional for Medical Device Technical File

-?Regulatory

-?Denmark - Hillerød


Would you like to have an impact on people’s lives by ensuring the compliance of Novo Nordisk’s documentation to external requirements? Do you have a talent for making precise and structured technical documentation and a drive for applying it in a regulated environment such as the medical device industry?


About the department

The position is located in the Design controls team in the Product Maintenance department. Product Maintenance holds the design responsibility for Novo Nordisk’s medical devices after the device design has been transferred from R&D to production. The Design controls team currently consists of skilled engineers with in-depth understanding of the design control process as well as technical expertise within mechanics, electronics, software and polymers. Each team member is responsible for one or more marketed products, for example our high-quality insulin pens and owns the product documentation.


The position

As Documentation Professional in Product Maintenance you will be a key person in ensuring that the technical file of our products lives up to all internal and external requirements. You will support the team in ensuring that the product fulfils the defined requirements and that safety risks are identified and mitigated by executing documentation updates based on the direction given by the technical experts.

Your tasks will include to update existing documentation in accordance with approved change requests and to drive and review change requests for update of documentation. You will write documentation for external authorities together with the technical experts in the department. If needed, you will provide input to stakeholders based on existing product documentation. You will also be a key person in supporting the team in audits and external inspections. In addition, you are encouraged to drive continuous improvement of the work processes surrounding the technical file.

You will work both independently with tasks in the team as well as participate in projects and meetings with several stakeholders where you represent the team. The position provides a unique opportunity to be involved in all aspects of a medical device in an international, pharmaceutical company. To succeed you collaborate with a broad range of stakeholders in the organisation such as Manufacturing Development, Regulatory Affairs, Quality Assurance, Global Safety and Research & Development.


Qualifications

You have a bachelor degree within a technical field or the field of communication. You possess 5+ years of experience within the development of medical devices with main tasks related to design control documentation including. You have documented training in external requirements related to medical device documentation and design controls. You will work in an international environment, hence solid skills in English is required.

You are well-structured and have a systematic way of working, seeking simple and effective solutions within the complexity that surrounds a medical device and its documentation package. You are service-minded and can handle a large number of tasks and stakeholders without losing focus. As a large part of your work will be related to documentation, you must possess excellent writing skills and you are known for your high quality deliverables.


Contact

For further information, please contact Linda Nilsson at +45 3075 0872.


Deadline

16 August 2017.


Please note that we will invite candidates for interviews continuously throughout the posting period.


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