Do you want to help bring groundbreaking innovations in life science to the market, creating real-world impact while gaining invaluable experience? We are looking for our new QA/RA specialist to join our team in our office in Copenhagen, Denmark. In this role, you'll bring your energy, curiosity and compliance mindset to help us shape our quality management system and build end-to-end regulatory documentation to support the CE-mark and global market expansion for our innovative product. We are seeking an enthusiastic, pragmatic and independent Regulatory Affairs and Quality Assurance Specialist to ensure that our QMS will be ISO 13485 ready and that our technical documentation will be in good shape. It's a truly exciting time to join our company just before our first commercial launch!
Key areas of accountability:
- Help build the quality management system to ensure its compliance with ISO 13485
- Act as coordinator for core quality processes, in tight collaboration with other functions
- Support creation and timely execution of regulatory strategies for Europe and market expansion
- Create end-to-end documentation for new product launch and maintenance on the market
- Assist with import/export compliance activities and drive QA/RA interactions with distributors
- Support post-market surveillance activities.
- Monitor and analyze emerging regulatory intelligence for the assigned regulatory areas.
- Participate in preparation and execution of audits/inspections.
What We Offer:
- A motivated and diverse team that values making everyday life in a startup both productive and fun
- Flexible working hours
- Hands-on insight into the inner workings of a med-tech startup and the process of bringing a product to market in the life sciences industry
- Access to a broad network in Denmark's startup ecosystem, especially in the life sciences sector
- Opportunities to build and refine a skill set that will serve you in startups, consulting, or similar roles
About Oasicare:
Oasicare is a med-tech startup based in Vesterbro, Copenhagen, focusing on women’s health. We are dedicated to developing innovative solutions that raise the standard of care for women and enhance quality of life for millions around the world.
How to Apply:
If you're ready to make an impact and gain hands-on experience in the startup world, send your CV and cover letter to alireza@oasi.care. For any questions, don’t hesitate to reach out.
Find out more about us at oasi.care.
