Quality and Regulatory GCP Engineer

Science is a clinical stage, vertically integrated technology company focused on solving some of neuroscience’s hardest questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility to patients who have lost it. To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry.

The QARA GCP Engineer will serve as the clinical and patient-facing operations expert within our Quality and Regulatory Affairs team, where each team member brings both quality and regulatory knowledge but specializes in a specific domain. This role focuses on ensuring the regulatory and quality compliance of clinical trials, patient safety initiatives, and post-market surveillance activities throughout Science's product lifecycle. The position combines clinical quality expertise, regulatory strategy, and project management skills to accelerate clinical development timelines while maintaining the highest standards of patient safety and GCP compliance.

This role will lead clinical regulatory submissions, establish clinical quality oversight procedures, and serve as the primary interface between clinical operations and regulatory requirements. While clinical focused, this position requires the ability to flex into other GxP activities as needed and assist in evolving and maintaining the Quality Management System (QMS).

Role responsibilities:

• Assist in developing and implementing regulatory strategies for new and modified products
• Lead cross-functional project teams to drive regulatory milestones, accelerate product development timelines, and ensure timely product launches while maintaining compliance standards
• Champion a flexible, risk-based approach to Quality and Regulatory compliance, coordinating sprint planning, backlog prioritization, and cross-functional meetings to keep projects on schedule.
• Prepare and review regulatory submissions (Technical Files, UKCA dossiers, PMA/Supplements, IDE, 510(k)) across multiple product portfolios simultaneously; interface with notified bodies and regulators to address questions and obtain clearances/approvals
• Interface with regulatory authorities on clinical matters, including pre-submission meetings, clinical hold responses, and inspection support
• Map out clinical and preclinical study needs for regulatory submissions, coordinating with cross-functional teams to ensure comprehensive study designs
• Develop and implement clinical trial quality oversight procedures, including monitoring plans, clinical SOPs, and compliance protocols
• Support clinical team in site qualification processes, ensuring GCP compliance and regulatory readiness across clinical sites
• Manage clinical trial quality incident (e.g. adverse events, device deficiencies) reporting, conducting quality investigations and root cause analysis, and interface with regulatory authorities on compliance and reporting requirements
• Lead CAPA, non-conformance investigations, management review, and trend analysis; translate field data into design or process improvements and proactively escalate safety signals
• Own creation and maintenance of comprehensive Risk Management Files (ISO 14971) for diverse product lines with varying regulatory pathways; author risk control packages and drive timely implementation of mitigations from design through post-market surveillance
• Provide strategic guidance on usability study requirements per IEC 62366, determining when studies are needed and ensuring regulatory compliance for human factors submissions
• Develop and execute post-market surveillance plans, including Post-Market Clinical Follow-up studies, clinical data collection, complaint handling, and vigilance reporting
• Establish and maintain clinical quality management systems, ensuring alignment with GCP, ISO 13485, and other applicable standards through design of efficient processes and tools
• Coordinate design reviews, verification/validation testing, and change-control justifications; ensure critical parameters are documented, justified, and tested prior to implementation
• Generate documentation required for regulatory submissions in collaboration with other departments (R&D, clinical, manufacturing)
• Create training programs for clinical personnel; ensure employees are trained to perform their work and that their training is documented

Key qualifications:

• Engineering Degree or equivalent in quality, regulatory and/or life sciences
• Minimum of 3 years of experience in clinical quality and regulatory affairs within medical device and/or biologics industry
• Demonstrated proficiency in GCP with proven ability to independently manage clinical compliance activities and serve as a subject matter resource
• Strong knowledge of medical device regulations, particularly MDR 2017/745, Good Clinical Practices, and ISO 14155, FDA…