Senior Product responsible with Safety Risk Management experience

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Hillerød

Are you ready to make a significant impact for the marketed products of [xxxxx] and contribute to enhance the lives of patients? Do you want to work with shield-activated devices for emergency use? This role offers a unique opportunity to utilize your Design Control skills while leveraging your expertise within risk management for medical devices. The position As Senior Product Responsible you will be responsible for life-cycle management and value growth of our single-dose device portfolio together with a small team of skilled and experienced colleagues. You will be driving the Design Control process in the post-launch phase of our products, striking the right balance between external and internal requirements, as well as ensuring effective problem solving in collaboration with a wide range of stakeholders. In this position you will furthermore use your expertise within Risk Management to develop robust and safe device variants for new patient groups. Your main tasks will include:
  • Ensuring patient safety through risk management of the marketed devices.
  • Ensuring overall compliance, quality and robustness of the marketed devices
  • Development of robust and safe device variants. Planning and coordinating risk management deliverables to ensure overall project timelines are met.
  • Preparing documents for submission to health authorities and providing support during subsequent regulatory interactions.
  • Involvement in various improvement projects to further develop the risk management domain.
    • Qualifications To thrive and succeed in this role, we believe you to have:
  • A bachelor’s degree or equivalent in engineering, natural science or a related field.
  • Expertise within Risk Management for medical devices (ISO14971)
  • High level of relevant experience in drug devices/combination products and have a strong knowledge within Design Controls.
  • Professional proficiency in both oral and written English is essential.
    • On a personal level, you are collaborative and use your great interpersonal skills to communicate openly, reach out to stakeholders across the organization, and facilitate meetings and workshops to reach decisions and ensure progress. You are analytical, structured and thrive on being detail-oriented while also being able to see the bigger picture. You approach your daily work with a healthy common sense and a good sense of humor. About the department In the Device Development department, we are approximately 80 highly skilled curious professionals and specialists that share the responsibility of the marketed device designs and serves as the link between Device R&D and production. In Device Development, the main task is to maintain marketed products as well as develop new variants of existing product platforms. Our deliverables have direct impact on our ability to deliver to the market, on patient safety, and on compliance with the requirements of the authorities. You will be part of a growing team of currently 7 colleagues who together share the ownership of a platform of single dose devices. Our department has a focus on serving the patients in the best way, but making sure that we have fun during the process. You will join a dynamic, international, and innovative environment, where highly skilled professionals work closely together to drive change. Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information about the position, please contact Line Brøgger at [xxxxx] or at +[xxxxx]. Deadline 1 April 2024. We are screening candidates and conducting interviews on an ongoing basis. To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 12.2.2024, men kan have været deaktiveret og genaktiveret igen.

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