Quality and Regulatory Engineer

Science Corporation•Alameda, CA

42d•$115,000 - $175,000

About The Position

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 Engineer drives the successful regulatory compliance of development, preclinical and clinical testing, manufacturing, commercialization, and post-market performance of Science's innovative product lines. This position blends quality, regulatory, and project management expertise with agile methodologies to accelerate time-to-market while safeguarding patient safety and regulatory compliance. This role will assist in evolving and maintaining the Quality Management System (QMS), drive regulatory submissions, and ensure adherence to relevant regulations.

Requirements

Engineering Degree or equivalent in quality, regulatory and/or life sciences
Minimum of 3 years experience spanning pre-clinical, clinical, manufacturing, and post-market phases of medical devices or biologics
Strong proficiency in at least one GxP discipline (e.g. GLP) with demonstrated ability to independently manage compliance activities and serve as a subject matter resource
Strong knowledge of medical device regulations, particularly MDR 2017/745, FDA 21 CFR Part 820, international quality standards, and global submission pathways
Ability to interpret standards and regulations into actionable requirements and documentation needs across varied technologies
Excellent communication skills with ability to work 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).

Nice To Haves

Experience with implantable medical devices, Class II-III medical devices, biologics, or combination products
Trained in internal and supplier audits
Experience with regulatory inspections and audit management (e.g. FDA, Notified Body)
Knowledge of multiple medical device regulation areas
Experience managing quality and regulatory activities across multiple product lines simultaneously
Working knowledge across multiple GxP disciplines (GLP, GCP, GMP) with ability to provide cross-functional support and adapt to different regulatory environments as business needs require
Proficiency with electronic QMS, PLM, and project-management tools (e.g., Asana)
Experience with preclinical study oversight, data integrity requirements, and laboratory quality systems

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
Support global registrations, inspections, and surveillance audits; compile objective evidence, facilitate on-site interactions, and drive timely response to findings.
Review device labeling and advertising materials for compliance with regulatory product approvals and applicable country regulations; analyze and recommend appropriate changes
Manage external documents and regulatory watch
Act as deputy for various functions as needed (e.g. the materiovigilance representative, Person Responsible for Regulatory Compliance according to Regulation 2017/745)
Contribute to materiovigilance activities, field corrective actions, and recall readiness
Develop, maintain, and drive continuous improvement to Science's Quality Management System (QMS) in alignment with ISO 13485, FDA 21 CFR 820, MDR 2017/745, and other applicable standards through design of efficient processes and tools
Lead comprehensive quality oversight of preclinical studies, ensuring GLP compliance and data integrity throughout the product development lifecycle
Design and implement quality assurance programs for preclinical testing facilities, including audit protocols, inspection procedures, and compliance monitoring
Lead CAPA, non-conformance investigations, management review, and trend analysis; translate field data into design or process improvements and proactively escalate safety signals
Work cross-functionally to identify and resolve quality issues, prioritizing based on product portfolio impact and business objectives
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
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)
Provide support to quality control and product development as required, with ability to rapidly context-switch between different product technologies
Provide quality oversight of contract manufacturers; execute supplier audits, production line inspections, and process validations to ensure continuous production readiness and material/component conformity
Develop and deliver quality system training programs that can be adapted for different product teams and regulatory requirements, ensure employees within project team have documented training