Regulatory Affairs Specialist
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
København
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.
- Apoteker
- København
Lignende jobs
-
Director, Global Regulatory Affairs - CMC
At [xxxxx], we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and th..Få mere info- Apoteker
- København
-
CLOSED - Regulatory Affairs Specialist
THE POSITION IS CLOSED AND DO NOT ACCEPT APPLICATIONSCerebriu, an award-winning health-tech startup, is at the forefront of revolutionizing the field of radiology through cutting-edge AI softwa..Få mere info- Apoteker
- København
-
Executive Management Assistant at Xellia Pharmaceu...
Are you ready to make a difference and play a crucial role in an organization dedicated to saving lives? Are you the person who cares about making your executives everyday life work, and have you d..Få mere info- Apoteker
- København
-
Manager, Global Regulatory Affairs, Operations, Su...
At [xxxxx], we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and th..Få mere info- Apoteker
- København
Statistik over udbudte jobs som apotekere i København
Herunder ser du udviklingen i udbudte apoteker i København over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal apotekere i København.
Se flere statistikker her:
Statistik over udbudte apotekere i København over tid
| Dato | Alle jobs som apotekere |
|---|---|
| 24. december 2024 | 15 |
| 23. december 2024 | 15 |
| 22. december 2024 | 15 |
| 21. december 2024 | 14 |
| 20. december 2024 | 15 |
| 19. december 2024 | 16 |
| 18. december 2024 | 16 |
| 17. december 2024 | 15 |
| 16. december 2024 | 16 |
| 15. december 2024 | 15 |
| 14. december 2024 | 16 |
| 13. december 2024 | 15 |
| 12. december 2024 | 16 |
| 11. december 2024 | 19 |
| 10. december 2024 | 21 |
| 9. december 2024 | 19 |
| 8. december 2024 | 19 |
| 7. december 2024 | 19 |
| 6. december 2024 | 20 |
| 5. december 2024 | 18 |
| 4. december 2024 | 18 |
| 3. december 2024 | 20 |
| 2. december 2024 | 20 |
| 1. december 2024 | 21 |
| 30. november 2024 | 20 |
| 29. november 2024 | 21 |
| 28. november 2024 | 18 |
| 27. november 2024 | 18 |
| 26. november 2024 | 16 |
| 25. november 2024 | 15 |
| 24. november 2024 | 17 |
Værd at vide når du søger job som apoteker i København
Mens København måske for nogle først og fremmest vækker billeder af hyggelige cafeer og historiske bygninger, banker et travlt erhvervsliv i hjertet af København. Hovedstaden huser et væld af brancher, men nogle skiller sig ud med et særligt højt antal ansatte.
Bydele i København
København byder på mere end smukke gader og hyggelige cafeer. De forskellige kvarterer har hver deres unikke atmosfære og erhvervsliv, hvilket kan påvirke din jobsøgning. Lad os dykke ned i nogle populære områder:
Indre By: Pulsens centrum med internationale virksomheder, finansverden og detailhandel. Perfekt for jobsøgende inden for finans, jura, medier og marketing. Tempoet er højt, og konkurrencen kan være hård.
Østerbro: En blanding af moderne boliger, historiske bygninger og innovative virksomheder. Hjem til Novo Nordisk og Vestas Wind Systems. Gode muligheder inden for life science, teknologi og bæredygtige løsninger.
Nørrebro: Multikulturelt og kreativt med studerende, kunstnere og små startups. Populært blandt unge fagfolk og jobsøgende inden for den kreative sektor og servicebranchen.
Vesterbro: Tidligere industriområde forvandlet til et trendy sted med restauranter, barer og designvirksomheder. Tiltrækker kreative sjæle og jobsøgende inden for mode, design og underholdning.
Valby: Familievenligt og roligt med gode skoler og grønne områder. Mange offentlige institutioner og virksomheder inden for service og administration. Attraktivt for børnefamilier og jobsøgende i den offentlige sektor.
Find ledige jobs i Valby
Amager: Et område i rivende udvikling med fokus på moderne arkitektur og bæredygtighed. Hjem til Ørestad og store virksomheder som DSV og Ørsted. Gode muligheder inden for logistik, energi og transport.
Mere information om København
Hvis du er på udkig efter et job i København, er det vigtigt, at du sætter dig grundigt ind i, hvordan jobmarkedet fungerer, og hvor i byen du vil arbejde og bo. Vi har samlet en guide med alle relevante oplysninger om København, så du kan få et samlet overblik. Læs mere om København i denne guide: København: Byen der byder på både drømmejob og spændende udfordringer