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Medical Device Regulatory Expert
3 weeks ago
We are seeking a highly skilled Medical Device Regulatory Expert to join our team at Cerebriu. As a key member, you will play a pivotal role in driving our regulatory and QA efforts.
Responsibilities:
- You will be responsible for preparing and managing regulatory submissions for our AI solutions in compliance with EU MDR, FDA, and other international regulatory requirements.
- Maintaining and developing our ISO 13485-certified QMS, specifically tailored to meet regulatory requirements for software-only medical devices, is also part of your responsibilities.
- You will collaborate with cross-functional teams to ensure agile compliance with regulations such as ISO 13485, 62304, 14971, MDR/MDD, and FDA.
- Participating in day-to-day regulatory and quality assurance activities, including planning and participation in internal and external audits, is also crucial.
Requirements:
As a candidate, 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.
- Strong knowledge of relevant standard and EU MDR and FDA regulations is essential.
- Experience in preparing and managing regulatory submissions is also required.
- Excellent written and oral communication skills in English are necessary, and proficiency in Danish is a plus.
- Detail-oriented with strong project management skills is also essential.
This is an excellent opportunity for a self-motivated individual who stays updated on regulatory changes and industry best practices.
