← All roles

Quality and Regulatory Engineer

Science Corporation· QARA (Quality and Regulatory Affairs)
Apply on company site
Hybrid (Multiple global locations including Durham, Paris, Alameda)$115k - $175kFull-timePosted 6mo ago

About the role

QARA Engineer role focused on regulatory compliance across preclinical, clinical, manufacturing, and post-market activities for Science’s medical devices and related products, with emphasis on ISO 13485, MDR, FDA regulations, and continuous QMS improvement.

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. materiovigilance representative, Person Responsible for Regulatory Compliance per REG 2017/745)
  • Contribute to materiovigilance activities, field corrective actions, and recall readiness
  • Develop, maintain, and drive continuous improvement to Science’s QMS in alignment with ISO 13485, FDA 21 CFR 820, MDR 2017/745 and other standards
  • Lead comprehensive quality oversight of preclinical studies ensuring GLP compliance and data integrity
  • Design and implement quality assurance programs for preclinical testing facilities, including audit protocols and inspection procedures
  • Lead CAPA, non-conformance investigations, management review, and trend analysis; translate field data into design or process improvements
  • Work cross-functionally to identify and resolve quality issues, prioritizing based on product portfolio impact
  • Own creation and maintenance of Risk Management Files (ISO 14971) for diverse product lines; author risk control packages and drive mitigations
  • Coordinate design reviews, verification/validation testing, and change-control justifications; ensure critical parameters are tested prior to implementation
  • Generate documentation required for regulatory submissions in collaboration with R&D, clinical, manufacturing
  • Provide support to quality control and product development; rapidly context-switch between product technologies
  • Provide quality oversight of contract manufacturers; execute supplier audits, production line inspections, and process validations
  • Develop and deliver quality system training programs adaptable for different product teams and regulatory requirements
  • Able to work onsite daily

Qualifications

  • 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
  • Experience with process validation (IQ/OQ/PQ) for equipment and manufacturing processes
  • 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)

Skills

Required:Regulatory strategyRegulatory submissionsQMS (ISO 13485, 21 CFR 820, MDR)Quality assuranceRisk management (ISO 14971)

Benefits

  • 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)
Last updated Oct 23, 2026. Interested? Apply on the company site.
Science Corporation logo

About Science Corporation

Transcend the limits of biology

Science Corporation is a clinical-stage medical technology company.

medical technologybrain-computer interfaceneural interfacesvision restorationneurotechnology
Company profileWebsite

More open roles at Science Corporation