Regulatory Affairs Specialist

Cerebriu, a pioneering health-tech startup, is revolutionizing the field of radiology with cutting-edge AI software. Our real-time brain MRI image interpretation enables dynamic workflow adaptation for radiologists. We are seeking a highly motivated and driven Regulatory Affairs Specialist to join our dynamic team.

As a Regulatory Affairs Specialist at Cerebriu, you will play a pivotal role in driving our regulatory and QA efforts. This position requires a hands-on approach, contributing to both regulatory submissions and daily QA tasks. Your expertise will ensure compliance with relevant regulations and standards for our software-only medical devices for AI-based medical image analysis.

Responsibilities:
You will assume a central and diverse role in our regulatory team, including preparation and management of regulatory submissions for our AI solutions in compliance with EU MDR, FDA, and other international regulatory requirements. To support this, you will also contribute to maintaining and developing our ISO 13485-certified QMS, specifically tailored to meet regulatory requirements for software-only medical devices.

• Keeping up to date with emerging trends and changes in regulatory legislation and guidelines, implementing necessary changes to processes and products, and liaising with international regulatory authorities to resolve any issues that may arise during the product certification process.
• Collaboration with cross-functional teams to ensure agile compliance with, e.g., ISO 13485, 62304, 14971, MDR/MDD, and FDA regulations.
• Participate in day-to-day regulatory and quality assurance activities, including planning and participation in internal and external audits.
• Assisting in the review and approval of promotional materials to ensure compliance with regulations.

Requirements:
We are looking for a candidate with a BSc or higher in a related field (e.g., life sciences, engineering) and a minimum of 5 years' experience in regulatory affairs within the medical device and/or software as a medical device industry.

• Strong knowledge of relevant standard and EU MDR and FDA regulations.
• Experience in preparing and managing regulatory submissions.
• Excellent written and oral communication skills in English; proficiency in Danish is a plus.
• Detail-oriented with strong project management skills.

We are a young and growing company, founded in 2018 with our main office in the center of Copenhagen. We've recently been awarded the Nordic Startup Award 2022, and EY's Startup/Scaleup of the Year (Copenhagen Region) 2022. We are a diverse team of nationalities, with backgrounds in computer science, medicine, radiology, engineering, anthropology, business, marketing etc. Team culture is important to us, and we strive hard to ensure a great work environment where everyone can have fun together.