Clinical Evaluation Specialist

Clinical Evaluation Specialist for regulatory writing

Do you have a passion for clinical and regulatory writing and have experience working with Medical Device Regulation requirements and clinical documentation? Then you may be our new Clinical Evaluation Specialist.

Job

Clinical Evaluation Specialist for regulatory writing

What will you do?

We are currently hiring a professional Clinical Evaluation Specialist to join our team. Your main responsibility will be to prepare and write clinical evaluation reports and other regulatory clinical assessment documentation. You will work closely together Regulatory Affairs, Compliance, and clinical audiologists to meet the requirements for clinical assessment in the medical industry.

Your main responsibilities will be to:

Create and write clinical evaluation plans, clinical evaluation reports, and post-market surveillance documents.
Work with stakeholders to gather relevant information.
Perform literature search and reviews.
Maintain current evaluation plans and reports.
Develop and maintain processes for clinical/regulatory writing.

You will be based at our headquarters in Middelfart and will report to Charlotte Ellemose Sonne, Communications Manager. Our other clinical evaluation specialist will be your buddy and closest collaboration partner within our team.

Who are you?

We expect that you have experience in regulatory writing and clinical evaluation in connection with medical devices.

The ideal candidate holds:

A bachelor’s or master’s degree in audiology, health care, life science, engineering or other relevant technical or scientific degree.
Knowledge of clinical research and regulatory requirements
Great communication and English skills
Experience in data analysis, literature search and review
Good interpersonal skills

If you have experience with audiological equipment, this is only an advantage.

You have great communication and English skills and have some years of experience within clinical documentation. You have good interpersonal skills and are good at building relationships with your colleagues. You know that it requires a team effort to write clinical evaluation reports and you are good at activating your stakeholders at the right time.

As a master of MS Office and as a structured individual, you are adept at transforming clinical knowledge and research into concise reports.

Company profile

We offer team spirit and a flexible working environment

We offer you the opportunity to become part of a large, growing international organization with high ambitions. You will join a team with skilled and enthusiastic colleagues and work in a friendly work environment based on collaboration, trust and respect. It is important to us that you feel well in your job. We provide thorough onboarding and training to make sure you can take on your new tasks, and we offer opportunities for personal and professional development.

Each day, we serve a delicious lunch in our canteen, and you can use our training facilities if you want to exercise. We have an active staff organization who organizes social events such Christmas and summer gatherings, and we also offer a strong health care scheme.