Job Description

Do you thrive in assessing clinical data Do you enjoy reviewing scientific literature following formalized, planned processes Are you able to see how simulated use and bench testing data could support your assessment Can you report evaluations transparently Then this might be your defining journey. Apply today and join us for a career #ForeverForward! The job As Ambu\'s new Clinical Evaluation Associate you will gain responsibility for performing clinical evaluations according to European Union regulations, and in line with and International (IMDRF) requirements. You will become responsible for maintaining the clinical documentation of your assigned products, which can be both during innovation and in the market. As a Clinical Evaluation Associate, you will work alongside Specialist level colleague(s) within your assigned area, taking on increased complexities over time and your development. Whenever you are assigned to an innovation project, you are a core member of the project team. Your innovation project deliveries start with setting a clinical strategy appropriate to projects scope before planning conducting and reporting the clinical evaluation. For marketed products you maintain the clinical evaluation documentation on an ongoing basis and assess requested design changes for relevant impact. Maintaining the documentation includes undertaking Post Market Clinical Follow-up activities according to post market surveillance (PMS) plans, and/or to fill any gaps you may have previously identified in the clinical data. Key Responsibilities Ensuring clinical documentation to the appropriate level for the product in line with the rest of clinical team and based on needs identified through your collaboration with colleagues spanning R&D, Marketing and Quality Assurance organizations. You will identify if any new clinical data is required, and conduct Post Market Clinical Follow-up activities accordingly. Further so, you will then continue to update clinical evaluations to maintain a benefit-risk assessment from any new data. We are a team of 15 Clinical Evaluation Associates and Specialists, reporting to Head of Clinical Development, Daniel Carter. We are part of the larger Regulatory and Clinical Affairs department which spans colleagues in Ambu HQ based in Ballerup, Denmark, and our innovation sites in Augsburg, Germany and Penang, Malaysia. The ideal candidate Setting you up for success is one of our cornerstones. In order to do so, we imagine you have experience from the Medical Device industry (or keen to get to know it), a degree within healthcare or science - what we are truly interested in, though, is your drive and skills. Furthermore, You Have awareness of clinical evaluation Can take ownership in solving and communicating relevant issues Have a positive, open mindset to respect and navigate varied perspectives or opinions Act with confidence in taking pragmatic, risk-based decisions when appropriate Ambu - a visionary and international workplace where your efforts matter As Ambu is a global company it is essential that you have excellent English skills and that you have a global mindset in relation to both co-workers and business opportunities. We offer a wide range of professional, social, and financial employee benefits along with exciting job challenges and career opportunities contributing to your job satisfaction. When to apply As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so no need to hesitate. For further inquiries please contact Head of Clinical Development, Daniel Carter, at +45 7225 2000 Your application will be treated confidentially.

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