Medical Writer

Join Us in Catalyzing Brain Health Therapy with Real-World Data

At UNEEG Medical, we are on a clear mission: improve epilepsy care and ultimately enhance patients’ quality of life through objective, real-world EEG data. Our sub-scalp EEG solution enables remote monitoring of brain activity and is already making an impact across Europe and the US. We are entrepreneurial and ambitious, blending the agility of a small company with the high standards expected in medical device industry.

Your role and team:

We are looking for a medical writer, who will play a key role in preparing and maintaining clinical and regulatory documentation to ensure compliance with medical device regulations and standards.

Our product portfolio consists of implantable, wearable and communication devices, which are class III medical devices in EU. We are already commercially available in Europe, and we are advancing towards US market entry. As a medical writer you will support activities across the product lifecycle, including clinical evaluation, regulatory submissions, and post-market surveillance, and contribute to continuous improvement and regulatory excellence through collaboration and clinical expertise.

You will be part of our Regulatory & Quality team that collaborates closely with colleagues across the organization and external consultants to achieve our common goals. In the team we are transparent about our challenges and step in to help others when needed. We continuously seek to improve our processes and personal knowledge.

Your main responsibilities will be:

• Prepare and maintain Clinical Evaluation Plans (CEPs) and Reports (CERs)
• Perform systematic literature reviews and appraise clinical data for regulatory purposes
• Write clinical evidence documentation for regulatory submissions (e.g. FDA submissions)
• Review and approve promotional claims and Instructions for Use (IFUs)
• Drive and facilitate the post-market surveillance process for products on the market
• Write post-market surveillance documentation e.g. Post Market Surveillance (PMS) plans, Post Market Clinical Follow up (PMCF) plans and Periodic Safety Update Reports (PSURs)
• Follow the legislation for clinical evaluation and post market surveillance for medical devices to ensure knowledge and understanding of regulatory demands
• Contribute to continuous improvement of processes to ensure regulatory compliance and excellence

You will thrive in this role if you have:

• Regulatory compliance knowledge – Quickly absorb new regulatory knowledge and medical writing best practices and translate it into your daily work
• A team-player mentality – Collaboration is fundamental in this role as you will be working closely with and proactively seeking guidance from colleagues across the organization
• A problem-solving mindset – Being pragmatic, resilient, and ready to take on new challenges as priorities shift

Your background:

• Minimum a bachelor’s degree, preferably within life science, clinical or medical science or similar
• Ideally, you have at least 3 years’ experience from a similar position within medical devices
• You have a background in clinical or medical writing, including systematic literature review and clinical data appraisal
• Experience with research methodology and information management
• Ability to interpret and implement regulations and guidance for medical devices

It will be an advantage if you have additional experience with:

• Post-market surveillance and post-market clinical follow-up
• Software as medical device (SaMD)
• Risk management, usability, and design control processes from a clinical perspective
• Neurology, epilepsy or the like
• Working with regulatory authorities in EU and US

Who are you as a person:

• You have a systematic and analytical approach when solving tasks
• You are pragmatic, and equally fond of working in the details and keeping the overview
• You have compelling technical writing and speaking skills
• You are excellent at planning your own work and can manage several tasks simultaneously
• You are fluent in English, spoken and written

Applicants must be eligible to work in Denmark and possess a valid work and residence permit if applicable. At this time, we are unable to support work permit applications or sponsorships.

What we offer:

• A tight-knit team with a collaborative spirit and high professional standards.
• A workplace with great energy, social activities, and a culture of togetherness.
• A role based in our modern HQ in Allerød with good facilities and easy access.

At UNEEG, your ideas matter, your work makes a difference, and your colleagues have your back.

Who to contact:

For more details about the job, please contact Senior Director, Regulatory & Quality, Camilla Wismar, at +45 4018 4937.

How to apply:

Please send your CV and application as soon as possible. All applications must be in English and are treated confidentially. We will screen and invite candidates for interviews on an ongoing basis.

About UNEEG Medical

UNEEG Medical pioneers ultra long-term subcutaneous EEG monitoring to help physicians optimize treatment for epilepsy patients. Our CE-marked UNEEG EpiSight solution provides objective insights into seizure burden, enabling more personalized care. We collaborate with leading institutions across Europe and the US to help patients regain control of their life. At UNEEG Medical, we are currently 40 dedicated people with diverse backgrounds. Our HQ is in Allerød with subsidiaries in UK, Germany, Austria and the US. Our core values Togetherness, Integrity, and Dedication guide our work as we catalyze brain health therapy with real-world data.

Apply with QuickApply on Jobindex.