Regulatory Expert for AI Solutions
4 days ago
Cerebriu is an ambitious health-tech firm at the forefront of transforming radiology through AI-powered software. Our real-time interpretation of brain MRI images empowers radiologists to optimize their workflows. We're currently seeking a seasoned Regulatory Affairs Specialist to collaborate with our skilled team.
This key role necessitates a meticulous approach, ensuring the accurate preparation and management of regulatory submissions and daily QA tasks. The ideal candidate will possess comprehensive knowledge of relevant regulations and standards for our software-only medical devices for AI-based medical image analysis.
Key responsibilities:
- Strategic preparation and management of regulatory submissions for our AI solutions in compliance with EU MDR, FDA, and other international regulatory requirements.
- Development and maintenance of our ISO 13485-certified QMS, tailored to meet regulatory requirements for software-only medical devices.
- Collaboration with cross-functional teams to ensure seamless compliance with, e.g., ISO 13485, 62304, 14971, MDR/MDD, and FDA regulations.
- Active participation in day-to-day regulatory and quality assurance activities, including planning and participation in internal and external audits.
The successful candidate should hold 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.
Essential qualifications include:
- Advanced knowledge of relevant standard and EU MDR and FDA regulations.
- Substantial experience in preparing and managing regulatory submissions.
- Superior written and oral communication skills in English; proficiency in Danish is a plus.
- Accurate project management skills.
A critical characteristic of the ideal candidate is a proactive and self-driven approach to driving regulatory processes forward. They should excel in a dynamic environment like Cerebriu, embracing the culture of scale-ups where continuous improvement is vital.
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