Quality and Regulatory GCP Engineer
Alameda, California, United States
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 clinical trial pathways, and international clinical trial requirements
- Experience with clinical trial operations, including site management, monitoring, and quality oversight
- Knowledge of adverse event reporting, clinical data management, and post-market surveillance requirements
- Ability to interpret standards and regulations into actionable requirements and documentation needs for clinical operations
- Excellent interpersonal and communication skills with exceptional ability to work with cross-functional teams and clinical sites across diverse technical teams
- Demonstrated success managing parallel projects in a fast-paced environment, balancing compliance rigor with agile execution to meet aggressive timelines
- Experience leading quality and regulatory initiatives
- Detail-oriented with strong organizational and problem-solving skills
- Ability to travel (domestic and international; to various company locations and third-party sites).
Preferred qualifications:
- Experience with implantable medical devices, Class II-III medical devices, biologics, or combination products
- Trained in internal and clinical site audits
- Experience with regulatory inspections and audit management (e.g. FDA, Notified Body)
- Knowledge of international clinical regulatory pathways (e.g. CE marking clinical requirements)
- Certification in clinical research (CCRA, ACRP) or quality systems
- Experience managing quality and regulatory activities across multiple product lines simultaneously
- Working knowledge across multiple GxP disciplines (GLP, GMP) with ability to provide cross-functional support and adapt to different regulatory environments as business needs require
- Proficiency with electronic QMS, eTFMs, and project-management tools (e.g. Asana)
Science is required under California law to include a reasonable estimate of the compensation range for this role. We determine your level based on your interview performance and make an offer based on the indicated salary band. The base salary range for this full-time position is $115,000-$175,000 annually + equity + benefits. Within the range, individual pay is determined by several factors, including job-related skills, experience, and relevant education or training. Please keep in mind that the equity portion of the offer is not included in these numbers.
Benefits:
At Science, our benefits are in place to support the whole you:
- Competitive salary and equity
- Medical, dental, vision and life insurance
- Flexible vacation and company-paid holidays
- Healthy meals and snacks provided for non-remote employees
- Paid parental, jury duty, bereavement, family care and medical leave
- Dependent Care Flexible Spending Account, subsidized by Science
- Flexible Spending Account
- 401(k)
