Clinical Evaluation Associate

JobsCloseBy Editorial Insights

Ambu A/S is seeking a Clinical Evaluation Associate in Augsburg to build and maintain MDR 2017/745 compliant clinical evaluations for Class I and II devices, collaborating with R&D, QA and Marketing to ensure robust, audit-ready documentation. You will conduct systematic literature reviews, identify evidence gaps, support PMCF activities and post-market surveillance, and contribute to design-change impact assessments. Based in the Augsburg hub, you will join a 14 strong Global Clinical Evaluation team reporting to the Clinical Evaluation Manager in Ballerup, with opportunities to grow. Ideal candidates hold a healthcare or science degree, understand MDR requirements, have clinical data analysis or medical writing experience, and are structured, proactive and collaborative. Apply with a concise CV and a cover letter linking your experience to MDR work and cross-functional projects, including concrete examples of literature reviews or documentation you produced, and a short note on your ownership mindset and attention to quality.

Clinical Evaluation Associate

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?

If so, this could be your next step.

The role

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.

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.

Key responsibilities

In this role, you will:

• Author and maintain high-quality clinical evaluation documentation in line with regulatory requirements, applying a structured and analytical approach
• Conduct systematic literature reviews to collect and assess clinical data supporting device safety and performance
• Identify evidence gaps and support Post-Market Clinical Follow-up (PMCF) activities to ensure evaluations remain current
• Perform impact assessments related to design changes and contribute to post-market surveillance (PMS) activities
• Collaborate cross-functionally with R&D, Marketing, and Quality Assurance to ensure documentation is accurate and fit for purpose
• Ensure documentation is robust, compliant, and audit-ready through a detail-oriented and structured way of working

Our team

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.

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.

Your profile

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.

You are likely to succeed in this role if you have:

• A degree in a healthcare or scientific field
• Knowledge of clinical evaluation processes and MDR (EU) 2017/745 requirements
• Experience in clinical data analysis and/or medical writing (medical device experience is an advantage)
• A structured and independent working style combined with strong collaboration skills
• A proactive and positive mindset, with a strong sense of ownership and attention to quality