Regulatory Affairs Specialist
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As a Regulatory Affairs Specialist at Cerebriu, you will play a pivotal role in driving our 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.
Responsibilities:
You will assume a central and diverse role in our regulatory team including preparation and management of regulatory submissions for our AI solutions in compliance with EU MDR, FDA, and other international regulatory requirements. To support this, you will also contribute in terms of maintaining and developing our ISO 13485-certified QMS, specifically tailored to meet regulatory requirements for software-only medical devices.
Further responsibilities include:
- Keeping up to date with emerging trends and changes in regulatory legislation and guidelines, implementing necessary changes to processed and products, and liaising with international regulatory authorities to resolve any issues that may arise during the product certification process.
- Collaboration 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.
- Assisting in the review and approval of promotional materials to ensure compliance with regulations.
What are we looking for:
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 including:
- Strong knowledge of relevant standard 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.
While experience with regulatory affairs beyond the European Union (EU) and the United States (US) is not mandatory, it is considered desirable. An understanding of the brain MRI / radiology domain would also be a great benefit.
But the most important part is your personality. You can work independently and as part of a team which is essential in a fast-paced and team-oriented environment like Cerebriu. You should thrive in such an atmosphere, exhibiting a proactive and self-driven approach to driving our regulatory processes forward. You are a self-motivated individual who stays updated on regulatory changes and industry best practices
Finally you embrace the culture of scale-ups, where things need to be invented and improved over time and you influence many areas of the company.
Who we are
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) 2022. 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.
Contact and application
In this recruitment process we are assisted by European Search Company. For additional information about the position please contact Søren Rosenkrantz, +45 28937977 or Brian Ranvits on +45 2048 0548.
Please note that applications are handled on an ongoing basis. So, send your application and CV as soon as possible using the application button on this page.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 10.7.2023, men kan have været deaktiveret og genaktiveret igen.
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