Job Description

Do you have solid knowledge about medical device development Can you manage the complexity of coordinating and aligning with medical, technical, quality, regulatory and commercial stakeholders And do you have experience conducting scientific literature review and writing Clinical Evaluation Reports Then Ambu might be your next career move. As Ambu\'s new Clinical Development specialist, you have the responsibility for clinical documentation of your assigned products during innovation and in the market. You will act as a core member of an innovation project team from project scoping phase to beyond product launch. Your primary project deliveries start with setting a clinical strategy appropriate to the aligned project scope, and you substantiate clinically pertinent aspects of performance are realized, before conducting and reporting the clinical evaluation. You do so through use of literature and national vigilance database searches, medical advice, relevant bench or pre-clinical simulations, and your knowledge of the framework surrounding medical device development. As Clinical Development Specialist your responsibilities will include: 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 the Innovation, Marketing, Quality and Regulatory Affairs organizations. You will identify any clinical data needed from a Post Market Clinical Follow-up perspective, and should new clinical data be required you will collaborate with our own growing operational team and/or a CRO as needed. For products on the market, you will continue to update clinical evaluations as appropriate, provide clinical input to relevant complaints, and support Post Market Surveillance with clinical data. You will join a team of 13 specialists, reporting to Head of Clinical Development, Daniel Carter. We are part of the Global Clinical Affairs department spanning Denmark HQ, and innovation hubs in Germany and Malaysia, and you will work from our HQ in Ballerup, Denmark. The ideal candidate Is a subject matter expert in medical device clinical development and clinical evaluation Works independently to take ownership in solving difficult and complex issues Acts with confidence in taking pragmatic, risk-based decisions when appropriate Can coach and guide both project and department colleagues Has a positive, open mindset to respect and navigate varied perspectives or opinions Your educational background will be scientific or from the healthcare professions. You are a good communicator with internal and external stakeholders. 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. About Ambu Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific. For more information, please visit ambu.com or follow us on LinkedIn.

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