Compliance Assistant - Student Position
About Scopio Labs
Scopio Labs is a fast-growing medical technology company transforming the fields of hematology and cell morphology analysis. As a team, we work to enable faster, earlier detection and diagnosis of blood-related diseases, so patients can start treatment sooner and have better outcomes. We are collaborative and global – and every individual at Scopio Labs is part of a life-saving mission.
What you'll be doing
As a part-time student member of our Compliance and Regulatory Affairs team, you’ll support the company’s regulatory activities and quality management systems. You’ll help ensure full compliance with standards such as those related to security and privacy, ISO 13485:2016, and 21 CFR 820. You will support internal audits and corrective efforts and help define quality procedures, protocols, and tools.
Your responsibilities will include:
- Supporting quality management activities such as supplier management, training management, product investigation process management, and document control
- Maintaining QMS systems and platforms
- Supporting the operations department in quality activities
The ideal student candidate will meet the following requirements
- Undergraduate degree candidate in industrial engineering, biotechnical engineering, life science, exact science, or law
- Experience with medical device regulation a plus
- Understanding of QA processes and methodologies such as ISO 13485:2016, ISO 9001:2015, or similar a plus
- Collaborative, motivated, detail-oriented, and independent
- Excellent communication skills in English, both written and verbal