Regulatory Affairs Specialist

Regulatory Affairs Specialist

Are you passionate about contributing to business growth and able to cut through complexity and drive regulatory strategies for high-impact projects through regulatory excellence?

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As Regulatory Affairs Specialist at UNEEG medical, you will be responsible for ensuring that UNEEG medical’s products and processes comply with relevant regulatory requirements. Responsibilities involve maintaining and improving regulatory processes by providing regulatory support and filing submissions to authorities. Furthermore, you will ensure that ongoing activities are in compliance according to current regulations such as MDR.

With direct report to Director QA/RA.

Your main tasks and responsibilities are:

• Ensure professional and proactive regulatory support in development projects
• Develop and execute regulatory strategies to ensure a fast-to-market approach
• Prepare regulatory documentation
• Contribute to the medical device regulatory intelligence review and monitoring
• Ensure vigilance reporting to authorities and conduct recalls, if necessary
• Provide regulatory assistance and advice to sales and other stakeholders

Your qualifications are a minimum of 5 years of experience with Regulatory work, preferably from a MedTech company, where you have gained experience with EU and US legislation for medical devices, including ISO 13485 and 21CFR 820 and regulatory submissions. It is an advantage if you are used to interfacing with international authorities and have gained strong knowledge in the interpretation of Medical Device regulations such as MDD/MDR/IVDR and FDA, including documentation and submission files in both the EU and the US. Preferably, you have knowledge of regulatory requirements for software (EN 62304), cybersecurity, and electronic equipment (EN 60601) and can interpret and convey it internally. You are fluent in Danish on all levels and possess great English skills.

You have a bachelor’s or master’s degree in a relevant field of natural science, e.g., Biomedical Engineering or similar, preferably with a technical background.

You are a team player who is able to collaborate with various functions and stakeholders, who has a structured and proactive approach, and who manages to keep an eye on the details while having the overall overview. As a person, you are creative and pragmatic and do not mind challenging traditional approaches by being inspired to find new and smart ways to fulfill quality requirements. You are a natural communicator who is also comfortable voicing your own opinions.

UNEEG medical offers a position allowing you to grow with an organization poised for growth in an entrepreneurial and social work environment. You will be part of an exciting and unique journey, accelerating the improvement of patients suffering from epilepsy.

Traveling: 0-10 days per year.

Domicile: In driving distance of the office in Allerød.

For more details about the job or the company, please contact CEO, Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25. All applications must be in English and are treated confidentially.