Inserat online seit: Veröffentlicht vor 4 Std.
<p style="text-align:center;margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><strong><span style="font-size:20.0pt;line-height:107%">Clinical Evaluation Associate</span></strong></p>
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<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Do you enjoy working with scientific data while navigating complex regulatory requirements? Are you motivated by reviewing literature and transforming insights into clear, high-quality documentation? And are you curious about—or already experienced in—the medical device industry?</p>
<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">If so, this could be your next step.</p>
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<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><strong>The role</strong></p>
<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">As a Clinical Evaluation Associate at Ambu, you will be responsible for creating, maintaining, and updating clinical evaluations for Class I and II medical devices in accordance with MDR (EU) 2017/745.</p>
<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">You will work closely with experienced colleagues and gradually take on more responsibility as you develop in the role. When involved in innovation projects, you will be part of the R&D core team, contributing from early clinical strategy through to planning, execution, and reporting.</p>
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<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><strong>Key responsibilities</strong></p>
<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">In this role, you will:</p>
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<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Author and maintain high-quality clinical evaluation documentation in line with regulatory requirements, applying a structured and analytical approach</li>
<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Conduct systematic literature reviews to collect and assess clinical data supporting device safety and performance</li>
<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Identify evidence gaps and support Post-Market Clinical Follow-up (PMCF) activities to ensure evaluations remain current</li>
<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Perform impact assessments related to design changes and contribute to post-market surveillance (PMS) activities</li>
<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Collaborate cross-functionally with R&D, Marketing, and Quality Assurance to ensure documentation is accurate and fit for purpose</li>
<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Ensure documentation is robust, compliant, and audit-ready through a detail-oriented and structured way of working</li>
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<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><strong>Our team</strong></p>
<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">You will be based in our innovation hub in Augsburg and become part of the Global Clinical Evaluation team, reporting to the Clinical Evaluation Manager in Ballerup.</p>
<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">You will join a collaborative and international team of 14 colleagues across Denmark and Malaysia. Together, we ensure high-quality and consistent clinical documentation across Ambu’s portfolio. We value knowledge sharing, trust, and a pragmatic approach to solving complex challenges.</p>
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<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><strong>Your profile</strong></p>
<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">We are committed to setting you up for success. While experience in the medical device industry is valuable, we are equally interested in your motivation, mindset, and potential.</p>
<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">You are likely to succeed in this role if you have:</p>
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<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">A degree in a healthcare or scientific field</li>
<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Knowledge of clinical evaluation processes and MDR (EU) 2017/745 requirements</li>
<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Experience in clinical data analysis and/or medical writing (medical device experience is an advantage)</li>
<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">A structured and independent working style combined with strong collaboration skills</li>
<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">A proactive and positive mindset, with a strong sense of ownership and attention to quality</li>
</ul>
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