Regulatory Affairs Expert for AI-Powered Medical Devices
2 days ago
Cerebriu, a pioneer in healthcare technology, is revolutionizing radiology through innovative AI software. Our real-time brain MRI image interpretation enables adaptive workflows for radiologists. We are seeking a motivated Regulatory Affairs Specialist to drive our regulatory efforts forward.
This position requires hands-on expertise in regulatory submissions and QA tasks. Your knowledge will ensure compliance with EU MDR, FDA, and international regulations for our AI-based medical devices.
Key Responsibilities:
- Prepare and manage regulatory submissions for our AI solutions, adhering to EU MDR, FDA, and other international requirements.
- Maintain and develop our ISO 13485-certified Quality Management System (QMS) to meet regulatory standards 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 issues during product certification.
- Collaborate with cross-functional teams to ensure agile compliance with ISO 13485, 62304, 14971, MDR/MDD, and FDA regulations.
- Participate in internal and external audits and assist in reviewing promotional materials for regulatory compliance.
Requirements:
- BSc or higher in a related field (e.g., life sciences, engineering).
- Minimum 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.
We estimate a salary range of $80,000 - $120,000 depending on qualifications and experience. Located in Hellerup Højsgårds Alle 78, Copenhagen Region, Denmark.
About Cerebriu:
Cerebriu is a growing company founded in 2018 with a main office in Copenhagen. We've received awards such as the Nordic Startup Award 2022 and EY's Startup/Scaleup of the Year (Copenhagen Region) 2022. Our diverse team consists of nationalities from computer science to medicine and engineering backgrounds. We strive for a great work environment where everyone can have fun together.
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Frederiksberg, Frederiksberg Kommune, Denmark European Search Company Full timeCerebriu, an award-winning health-tech startup, is pioneering the revolution in radiology with cutting-edge AI software. Our real-time brain MRI image interpretation enables dynamic workflow adaptation for radiologists.We're seeking a highly motivated and driven Regulatory Affairs Specialist to join our dynamic team. As a key member of our regulatory team,...
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Frederiksberg, Frederiksberg Kommune, Denmark European Search Company Full timeCerebriu, a cutting-edge health-tech startup, revolutionizes radiology with AI software. Our real-time brain MRI image interpretation enables dynamic workflow adaptation for radiologists. As we continue to innovate, we seek a driven Regulatory Affairs Specialist to join our dynamic team.As a Regulatory Affairs Specialist at Cerebriu, you will play a crucial...
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