Quality and Regulatory Engineer

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
• 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
• Design and implement quality assurance programs for preclinical testing facilities, including audit protocols, inspection procedures, and compliance monitoring
• Lead comprehensive quality oversight of preclinical studies, ensuring GLP compliance and data integrity throughout the product development lifecycle
• 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
• Career development and delivery of quality system training programs that can be adapted for different product teams and regulatory requirements, ensure employees within project team have documented training
• Provide support to quality control and product development as required, with ability to rapidly context-switch between different product technologies
• 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
• 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
• 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
• 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

Key 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
• 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
• Detail-oriented with strong organizational and problem-solving skills
• Able to work onsite daily