Regulatory Affairs Analyst

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.

About the job

We are looking for a regulatory affairs (RA) analyst to join our compliance and RA team. The team is responsible for Scopio’s regulatory activities, quality management system, and ensuring compliance with applicable standards, including those related to privacy.

The team plays a central role in both pre-market and post-market activities at Scopio. Your responsibilities will include supporting the company's global regulatory activities, ensuring compliance with relevant quality standards (including ISO 13485:2016 and 21 CFR 820), and supporting internal audits and post-market activities.

As an analyst, you will:

• Prepare regulatory submissions and conformity assessments for regulatory authorities
• Support the company’s regulatory activities by analyzing regulatory requirements in diverse territories and continually monitoring the regulatory environment
• Assist in preparation, review, and submission of marketing authorization applications
• Promote the company’s quality management system
• Contribute to development and implementation of regulatory strategies, including assessing regulatory impact on product development
• Collaborate with cross-functional teams such as R&D, product, and clinical teams to support regulatory submissions
• Support the preparation and maintenance of technical documentation and regulatory files in compliance with applicable standards (ISO 13485, 21 CFR 820. IVDR)
• Provide ongoing support to Scopio’s quality management activities
• Support post-market surveillance activities

The ideal candidate will have:

• A relevant bachelor’s degree (eg. law, industrial engineering, biotechnology engineering, life science, exact science)
• Minimum 2 years experience in medical devices RA
• Knowledge of US and EU regulations (experience with an IVD medical device - advantage)
• Understanding of quality assurance processes and methodologies (ISO 13485:2016, ISO 9001:2015 or similar)
• A motivated, collaborative, and proactive approach to work
• Ability to collaborate effectively with cross functional teams, including R&D, product, quality assurance and marketing to achieve regulatory objectives
• Excellent communication skills (both written and verbal)
• Strong attention to detail
• English proficiency