Medical Writer

UNEEG Medical / Fuldtid

Slået op: 20.12.2024

About UNEEG Medical

UNEEG medical A/S is a dynamic and pioneering company in the field of medical technology. The company is committed to improving the quality of life for epilepsy patients through innovative solutions that revolutionize epilepsy treatment.

UNEEG medical’s mission is to enable continuous measurement and collection of EEG data 24/7, providing patients and healthcare professionals with deeper insights into the brain. These insights can enhance patient care by optimizing the treatment and management of epileptic seizures. UNEEG medical is at the forefront of cognitive technologies for monitoring and analyzing EEG data, with a strong presence in the European market and preparations for expansion into the USA.

With headquarters in Allerød, Denmark, UNEEG medical employs around 70 dedicated professionals across Europe. As part of this family-owned company, you’ll have the opportunity to contribute to the development and marketing of groundbreaking solutions for epilepsy patients while being part of a unique and innovative culture.

About the department

The Medical Writer will join a specialized team of experts in quality assurance, regulatory affairs, and clinical development. This small team collaborates closely with internal stakeholders, suppliers, and external partners to ensure regulatory compliance and deliver high-quality medical devices. Reporting to the Senior Director you will benefit from the extensive technical leadership while taking ownership of your area of expertise. The department emphasizes collaboration and professional growth, providing opportunities to deepen your understanding of epilepsy and clinical environments.

About the position

UNEEG medical is seeking a skilled Medical Writer to play a vital role in communicating clinical data for medical devices (Class I and III), clearly and effectively support regulatory approvals. You will be responsible for drafting, maintaining, and reviewing clinical documentation, ensuring it meets global regulatory standards. This role involves preparing clinical evidence for regulatory submissions, including FDA applications, and collaborating with regulatory affairs specialists to support the US market entry strategy. You will also lead post-market surveillance activities, ensuring compliance throughout the product lifecycle.

Key responsibilities

As Medical Writer your key responsibilities will be:

• Clinical Documentation: Prepare and maintain Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs).
• Literature Reviews: Conduct systematic literature reviews and safety assessments.
• Regulatory Submissions: Draft clinical evidence for regulatory submissions, including FDA applications.
• Post-Market Surveillance: Lead and facilitate post-market surveillance processes, including writing PMS plans, PMCF plans, and PSURs.
• Review and Approval: Evaluate and approve promotional claims and Instructions for Use (IFUs).
• Legislative Compliance: Stay informed of evolving clinical evaluation and post-market surveillance legislation for medical devices.
• Cross-Functional Collaboration: Work closely with teams across the organization to ensure compliance and safety during the product lifecycle.
• Process Improvement: Contribute to the continuous improvement of regulatory and clinical processes.

About you

• Proven experience as a Medical Writer in the medical device industry, preferably with Class I and III devices. 
• Familiarity with regulatory standards, including FDA submissions and EU MDR requirements. Experience with complex medical devices, particularly those involving electronics or software (SaMD). 
• Strong skills in clinical evaluation and systematic literature reviews. 
• A degree in a scientific or healthcare-related field (e.g., life sciences, biomedical engineering). 
• Excellent communication and collaboration skills.

Join the UNEEG Team

At UNEEG medical, you will be part of a mission-driven team dedicated to improving patient outcomes through groundbreaking medical technology. The company offers a dynamic and supportive work environment where your expertise will play a pivotal role in shaping the future of epilepsy treatment. 

If you are ready to contribute to innovative medical solutions and thrive in a collaborative culture, apply today to join UNEEG medical’s journey of transforming patient care.

Capax Recruitment is assisting UNEEG Medical in this recruitment. For further information please contact Vjollca Muaremi vmu@capax.dk.