Clinical Evaluation Associate

Ambu A/S; Ballerup Kommune; On-site; DKK 50,000 - 70,000; Full time

Job summary

Ambu A/S is seeking a Clinical Evaluation Associate to create and maintain clinical evaluations forClass I and II medical devices in Ballerup, Denmark. You will work closely with experienced colleagues to contribute from early clinical strategy to planning and execution.

The ideal candidate holds a degree in a healthcare field and possesses knowledge of regulatory requirements. Emphasis is placed on collaboration and a proactive approach, with opportunities to grow in a supportive team environment.

Qualifications

• 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.

Responsibilities

• Author and maintain high-quality clinical evaluation documentation.
• Conduct systematic literature reviews to collect and assess clinical data.
• Collaborate cross-functionally with R&D, Marketing, and Quality Assurance.

Skills

Clinical evaluation processes

Clinical data analysis

Medical writing

Collaboration skills

Proactive mindset

Education

Degree in healthcare or scientific field

Job description

City: Ballerup

Country/Region: Denmark

State:

Business Area: Clinical Research

Department: Clinical Development

Employment Type: Full-time

Req ID: 10354

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

• 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 Headquarters in Ballerup and become part of the Global Clinical Evaluation team, reporting to the Clinical Evaluation Manager. 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