Check out our open positions below. We look forward to hearing from you.
Compliance & RA Student position
About The Position
Scopio Labs is a fast-growing biotech 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.
We are looking for a part time student to join our Compliance and RA team. Scopio’s Compliance and RA team is responsible for the company’s regulatory activities, quality management system, and for ensuring compliance with applicable standards, including standards related to security and privacy.
The team plays a central role in both pre-market and post market activities. The position entails an important role in the company’s regulatory, quality and compliance activities, including – ensuring compliance with the relevant quality standards (including ISO 13485:2016 and 21 CFR 820); Supporting internal audits, corrective efforts and different quality projects, defining quality procedures, protocols and tools.
What you’ll be doing
- Provide ongoing support to the company’s quality management activities such as supplier management activities, training management, product investigation process management, document control etc;
- Maintenance of the Company’s QMS systems and platforms;
- Support the Operations department in quality activities.
- Bachelor Student in Industrial Engineering, Bio-technology Engineering, Life Science/ Exact Science and Law.
- Experience with medical device’s Regulatory Affairs (RA) – Advantage.
- Understanding of Quality Assurance processes and methodologies (ISO 13485:2016, ISO 9001:2015 or similar) – Advantage
- Team player
- Self-learner, highly motivated and independent individual
- Excellent communication skills (both written and verbal)
- Strong attention to details
- English Proficiency