Regulatory Affairs Specialist

This role is based in Allerød.

 

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 Regulatory Affairs team at UNEEG medical is a small but essential group that works closely with suppliers, external partners, and internal stakeholders to ensure that products comply with regulatory standards. The team is currently composed of specialists in quality assurance, regulatory affairs, and clinical development. As part of the team, you will work in collaboration with a regulatory affairs specialist and other experts to ensure that UNEEG’s products meet the regulatory requirements for both European and U.S. markets. Reporting to the Senior Director, you will be the expert in your field, with a focus on maintaining regulatory compliance and driving improvements across the organization.

About the position

UNEEG medical is looking for a Regulatory Affairs Specialist to take ownership of regulatory responsibilities and ensure compliance across the organization. This role involves preparing and maintaining regulatory documentation, supporting registration processes, and working with various teams to ensure that new devices and changes to existing devices meet regulatory requirements. You will be the key point of contact for regulatory matters, helping the company navigate the complexities of the regulatory landscape for medical devices.

Responsibilities

• Regulatory Documentation: Prepare and maintain regulatory documents such as Labelling Strategies, GSPR Checklists, Technical Documentation Summaries, EU Declarations of Conformity, and other regulatory statements.
• Market Registration: Support the registration of products in existing and new markets by preparing regulatory submissions, managing responses, and ensuring timely approvals.
• Customer Complaints & Vigilance: Evaluate customer complaints to determine reportability and prepare vigilance reports for submission to authorities when necessary.
• Post-Market Surveillance: Lead post-market surveillance activities by managing processes and writing documents like PMS plans and PSURs to meet regulatory standards.
• Regulatory Compliance: Ensure that regulatory information is kept up-to-date in relevant systems, such as EUDAMED, and stay informed about changes in laws, guidance, and standards.
• Cross-Functional Collaboration: Work with various teams to ensure regulatory compliance for new devices and updates to existing devices.
• Process Improvements: Contribute to continuous improvements in regulatory affairs processes, ensuring that products remain safe throughout their lifecycle.

Qualifications

• Proven experience in regulatory affairs, specifically within the medical device industry (class I and III).
• Strong understanding of regulatory documentation, such as EU Declarations of Conformity, technical files, GSPR checklists, and post-market surveillance documents.
• Technical experience with electronics or software devices is essential, especially for complex medical devices.
• Strong ability to review and approve promotional materials, and evaluate customer complaints for regulatory reporting.
• Experience with systems like EUDAMED and a solid understanding of the regulatory landscape.
• Ability to collaborate across functions and drive regulatory compliance throughout the product lifecycle.
• Strong communication and organizational skills, with the ability to drive continuous improvement within the regulatory affairs function.

Join the UNEEG Team

If you are passionate about regulatory affairs and eager to make an impact in the medical technology field, UNEEG medical offers an exciting and dynamic work environment. Join a company that is dedicated to improving the quality of life for epilepsy patients and be a part of an innovative team that is shaping the future of medical diagnostics.

Capax Recruitment is assisting UNEEG Medical in this recruitment. For further information please contact Vjollca Muaremi [email protected].