Maclivaro Limited · 15 hours ago
Quality Regulatory Manager
Austin, Texas Metropolitan Area
Contract
Onsite
Senior Level, Lead/Staff
10+ years expMaclivaro Limited is a high-growth, early-stage tech/medical device organization seeking an experienced Fractional QARA Manager. This role involves building and maintaining a robust quality and regulatory framework, ensuring compliance with FDA and global standards, and driving quality excellence across the organization.
Staffing & Recruiting
Hiring Manager
Olivia MacDonald
Responsibilities
Lead deployment and maintenance of quality management systems (QMS) aligned with FDA, ISO and global standards
Draft, organise, and maintain technical files and design history documentation
Ensure documentation readiness for audits, inspections, and regulatory submissions
Develop and execute regulatory strategies for product clearances/approvals (e.g., FDA, CE/MDR)
Prepare and submit regulatory filings (510(k), IDE, etc.) and manage correspondence with regulatory authorities
Advise cross-functional teams on regulatory impact and compliance requirements
Own risk management processes (FMEA, hazard analysis, risk controls) and ensure integration across the product lifecycle
Drive corrective and preventive action (CAPA), complaint handling, and change control
Ensure training and adherence to quality standards across the organisation
Write and review SOPs, test protocols, validation documents, and quality records
Collaborate with engineering, clinical, operations and manufacturing teams to ensure quality and regulatory priorities are met
Be comfortable rolling up your sleeves — this role requires execution, not just oversight
Qualification
Required
10+ years in quality/regulatory roles within medical device
Proven track record with FDA submissions and global regulatory frameworks
Deep understanding of QMS, design controls, risk management and compliance
Comfortable working in dynamic, early-stage environments wearing multiple hats
Able to translate regulatory expectations into actionable plans
Company
Maclivaro Limited
Maclivaro is a family-run consultancy specialising in recruitment for medical devices, engineering, and the life science sector.
Founded in 2025
2-10 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase