Regulatory Affairs Specialist
7 days ago
Cerebriu, a pioneering health-tech company, is revolutionizing the field of radiology through cutting-edge AI software. Our real-time interpretation of brain MRI images enables dynamic workflow adaptation for radiologists. As we continue to innovate, we are seeking a highly motivated and driven Regulatory Affairs Specialist to join our dynamic team.
Key Responsibilities- Drive regulatory and QA efforts, ensuring compliance with relevant regulations and standards for our software-only medical devices for AI-based medical image analysis.
- Assume a central role in our regulatory team, preparing and managing regulatory submissions for our AI solutions in compliance with EU MDR, FDA, and other international regulatory requirements.
- Maintain and develop our ISO 13485-certified QMS, specifically tailored to meet regulatory requirements for software-only medical devices.
- Stay up-to-date with emerging trends and changes in regulatory legislation and guidelines, implementing necessary changes to processes and products.
- Liaise with international regulatory authorities to resolve any issues that may arise during the product certification process.
- Collaborate 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.
- Assist in the review and approval of promotional materials to ensure compliance with regulations.
- BSc or higher in a related field (e.g., life sciences, engineering).
- Minimum of 5 years' experience in regulatory affairs within the medical device and/or software as a medical device industry.
- Strong knowledge of relevant standards 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.
Cerebriu is 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). 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.
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