Senior Medical Writer - part time

at  Demant

We provide the evidence to show our hearing aids live up to the highest standards. It’s as simple as that. How we do it not so simple, and that’s why we need you!
In collaboration with the other senior medical writers in the clinical affairs team, you ensure, that the clinical evidence for our hearing solutions is established and maintained throughout the entire device life cycle.
Sounds like you? Then read on!

PROVIDING THE EVIDENCE

The position and the team are quite central because we directly influence the development and improvement of advanced hearing solutions, ensuring they meet the highest clinical standards and regulatory requirements, and in the end, improve the lives of our users.
Specifically, you will be responsible for writing the clinical evaluations and post market clinical follow-up (PMCF) files, including for example systematic literature reviews, and assessing technical documentation. Our device portfolio of hearing solutions ranges from EU MDR class I to class IIa medical devices, wireless electronic devices with both embedded and standalone software and accessories. We keep an eye on the market and are continuously in dialogue with stakeholders throughout the company.
“There is increased focus on our area of expertise, and we are seen as a valuable and essential part of the device life cycle. Boiled down, we provide the clinical evidence that our devices are safe to use and perform the way they are required to, so our users can receive the best help possible to aid their hearing loss.” tells Anja, Manager of the Clinical Affairs team, and continues “And that is why we are looking for an additional colleague to join our team.”
As part of the clinical affairs team, you will also participate in strategic projects aimed at optimizing procedures and standard operating practices (SOPs), enhancing your skills in medical writing and regulatory affairs.

MEDICAL WRITER WITH MEDTECH EXPERIENCE

You are likely to have a degree within audiology, health tech/science, or similar and have solid experience from working with either hearing aids or other medical devices (EU MDR class IIa or higher).
You know your way around research methodology, information management and medical writing and you have a good understanding of regulatory requirements for medical devices. You also know how to prepare clinical evaluations and PMCF files for EU MDR class IIa (active) medical devices.
To ensure the team meets timelines, you must be good at planning, work structured, be proactive when problems arise, and seek input and advice from relevant colleges across the organization.
You are pragmatic, and equally fond of working in the details and keeping the overview.
This part-time (30 hours/week) position is based at the Demant Head Office in Smørum, Denmark. How you want to structure your hours is something we will agree on together.

Please refer the Job description for details