Quality and Regulatory 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 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.Role ResponsibilitiesAssist in developing and implementing regulatory strategies for new and modified productsLead cross-functional project teams to drive regulatory milestones, accelerate product development timelines, and ensure timely product launches while maintaining compliance standardsChampion 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/approvalsSupport 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 changesManage external documents and regulatory watchAct 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 readinessDevelop, 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 toolsLead comprehensive quality oversight of preclinical studies, ensuring GLP compliance and data integrity throughout the product development lifecycleDesign and implement quality assurance programs for preclinical testing facilities, including audit protocols, inspection procedures, and compliance monitoringLead CAPA, non-conformance investigations, management review, and trend analysis; translate field data into design or process improvements and proactively escalate safety signalsWork cross-functionally to identify and resolve quality issues, prioritizing based on product portfolio impact and business objectivesOwn 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 surveillanceCoordinate design reviews, verification/validation testing, and change-control justifications; ensure critical parameters are documented, justified, and tested prior to implementationGenerate 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 technologiesProvide quality oversight of contract manufacturers; execute supplier audits, production line inspections, and process validations to ensure continuous production readiness and material/component conformityDevelop and deliver quality system training programs that can be adapted for different product teams and regulatory requirements, ensure employees within project team have documented trainingKey QualificationsEngineering Degree or equivalent in quality, regulatory and/or life sciencesMinimum of 3 years experience spanning pre-clinical, clinical, manufacturing, and post-market phases of medical devices or biologicsStrong proficiency in at least one GxP discipline (e.g. GLP) with demonstrated ability to independently manage compliance activities and serve as a subject matter resourceStrong knowledge of medical device regulations, particularly MDR 2017/745, FDA 21 CFR Part 820, international quality standards, and global submission pathwaysAbility to interpret standards and regulations into actionable requirements and documentation needs across varied technologiesExcellent communication skills with ability to work across diverse technical teamsDemonstrated success managing parallel projects in a fast-paced environment, balancing compliance rigor with agile execution to meet aggressive timelinesExperience leading quality and regulatory initiativesDetail-oriented with strong organizational and problem-solving skillsAbility to travel (domestic and international; to various company locations and third-party sites).Preferred QualificationsExperience with implantable medical devices, Class II-III medical devices, biologics, or combination productsTrained in internal and supplier auditsExperience with regulatory inspections and audit management (e.g. FDA, Notified Body)Knowledge of multiple medical device regulation areasExperience managing quality and regulatory activities across multiple product lines simultaneouslyWorking knowledge across multiple GxP disciplines (GLP, GCP, GMP) with ability to provide cross-functional support and adapt to different regulatory environments as business needs requireProficiency with electronic QMS, PLM, and project-management tools (e.g., Asana)Experience with preclinical study oversight, data integrity requirements, and laboratory quality systemsScience 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.BenefitsAt Science, our benefits are in place to support the whole you:Competitive salary and equityMedical, dental, vision and life insuranceFlexible vacation and company-paid holidaysHealthy meals and snacks provided for non-remote employeesPaid parental, jury duty, bereavement, family care and medical leaveDependent Care Flexible Spending Account, subsidized by ScienceFlexible Spending Account401(k)Science Corporation is an equal opportunity employer. We strive to create a supportive and inclusive workplace where contributions are valued and celebrated, and our employees thrive by being themselves and are inspired to do their best work.We seek applicants of all backgrounds and identities, across race, color, ethnicity, national origin or ancestry, citizenship, religion, sex, sexual orientation, gender identity or expression, veteran status, marital status, pregnancy or parental status, or disability. Applicants will not be discriminated against based on these or other protected categories or social identities. Science will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state and local laws.Apply now