Regulatory Affairs Specialist: Pivotal Role in Medical Device Compliance
3 weeks ago
Cerebriu, 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 role in driving 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.
Key Responsibilities:
- You will assume a central and diverse 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.
- You will contribute to maintaining and developing our ISO 13485-certified QMS, tailored to meet regulatory requirements for software-only medical devices.
- You will keep 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.
- You will collaborate with cross-functional teams to ensure agile compliance with, e.g., ISO 13485, 62304, 14971, MDR/MDD, and FDA regulations.
- You will participate in day-to-day regulatory and quality assurance activities, including planning and participation in internal and external audits.
- You will assist in reviewing and approving promotional materials to ensure compliance with regulations.
Requirements:
- You have 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.
- You have strong knowledge of relevant standard and EU MDR and FDA regulations.
- You have experience in preparing and managing regulatory submissions.
- You possess excellent written and oral communication skills in English; proficiency in Danish is a plus.
- You are detail-oriented with strong project management skills.
Benefits:
- We offer an estimated salary of around €80,000 - €100,000 per year, depending on your experience.
- You will work in a fast-paced and team-oriented environment like Cerebriu.
- You will thrive in a culture where things need to be invented and improved over time.
About Us:
Cerebriu is a young and growing company, founded in 2018 with our main office in Copenhagen. We've recently been awarded the Nordic Startup Award 2022 and EY's Startup/Scaleup of the Year (Copenhagen Region) 2022.
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