VP Regulatory Affairs and Compliance

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 our technology

Scopio has developed a digital imaging platform using novel computational photography. Built on top of this breakthrough technology is Scopio’s clinical-grade AI that automatically analyzes blood samples at the highest resolution available and in minutes. Scopio Labs has secured FDA clearance for its Full-Field Peripheral Blood Smear Application and Full-Field Bone Marrow Aspirate Application and its technology is in commercial use at hospitals and labs in the US, Europe, and Israel.

About the position

We are looking for a strategic and experienced VP of Regulatory Affairs and Compliance to lead Scopio Labs' regulatory, compliance, and quality efforts as we expand globally. In this critical leadership role, you will ensure our products meet the highest regulatory and quality standards while fostering a culture of accountability, integrity, and operational excellence.

The ideal candidate will bring a deep understanding of global regulatory environments, hands-on experience managing Quality Management Systems (QMS), and a proactive approach to compliance. You will work closely with cross-functional teams, regulatory authorities, and executive leadership to navigate complex regulatory landscapes, ensure the success of product launches, and maintain Scopio’s reputation for innovation and quality.

This position is reporting to the Chief Product Officer

Key Responsibilities

Regulatory Affairs

• Develop and execute regulatory strategies to support the global launch and approval of Scopio’s products.
• Lead interactions with regulatory authorities to secure and maintain required certifications and approvals.
• Ensure compliance with applicable standards for both existing and emerging markets.
• Provide strategic input during product development to ensure regulatory requirements are met throughout the lifecycle.

Compliance Oversight

• Establish, implement, and oversee a comprehensive compliance framework, addressing local, national, and international regulatory requirements.
• Lead the implementation and maintenance of the company’s Quality Management System (QMS) in accordance with global standards (e.g., ISO 13485, 21 CFR).
• Define, oversee, and continuously improve quality processes and procedures, including document control, corrective and preventive actions (CAPA), risk management, and supplier quality management.
• Monitor changes in regulatory environments and proactively update policies, processes, and the QMS to maintain compliance.
• Ensure marketing, labeling, and promotional activities align with regulatory and quality guidelines.
• Develop risk management strategies and ensure robust reporting mechanisms for compliance and quality issues.
• Oversee the review and approval of all product quality documentation, including validation protocols, risk assessments, and quality reports.
• Conduct internal and supplier audits to ensure adherence to quality and compliance standards, identifying and addressing gaps proactively.

Leadership & Collaboration

• Serve as the primary advisor to executive leadership on regulatory, compliance, and quality matters.
• Build and manage a high-performing regulatory, compliance, and quality team.
• Educate employees and foster a culture of compliance and quality through training programs and ongoing communication.

Qualifications

• Advanced degree in a relevant field (e.g., Regulatory Science, Law, Life Sciences, or equivalent).
• Minimum of 10 years of experience in regulatory affairs, compliance, and quality management, at least 6 of which in the medical device sector.
• Proven success in securing regulatory approvals and maintaining QMS compliance across multiple geographies.
• Strong understanding of global regulatory frameworks and quality standards.
• Exceptional strategic thinking and problem-solving skills.
• Strong interpersonal and communication abilities to navigate complex regulatory and quality landscapes.
• Demonstrated leadership experience in building and managing diverse teams.
• Proactive, detail-oriented, and highly organized with a results-driven mindset.