Lead complex cross-functional RAQA projects from initiation to completion while managing project plans, budgets, and stakeholder communication. Ensure compliance with global regulatory standards and quality systems while driving continuous improvement in project management processes.
What You’ll Do:
Lead medium to high complexity cross-functional RAQA projects from initiation through completion
Develop and maintain project plans, schedules, budgets, resource plans, communication plans, and related documentation
Partner with functional leaders to define project scope, objectives, deliverables, milestones, and success criteria
Coordinate activities across Regulatory Affairs, Quality Assurance, R&D, Operations, Supply Chain, Manufacturing, Clinical, Marketing, Finance, and external partners
Facilitate cross-functional meetings and ensure decisions, action items, risks, and dependencies are documented and managed
Monitor project progress and communicate status, risks, issues, and mitigation plans to stakeholders and leadership
Identify project risks and develop mitigation and contingency plans
Manage project scope, schedule, cost, and quality while balancing competing priorities
Drive resolution of project issues through collaboration across functional teams
Support implementation of new regulatory requirements, quality initiatives, remediation activities, product changes, and compliance projects
Ensure projects comply with internal quality system requirements and applicable global regulatory standards
Track project financials, including budget forecasts and actual expenditures
Support continuous improvement of project management processes, tools, and best practices
Provide coaching and mentoring to less experienced project managers and team members
Present project updates and recommendations to senior management and project sponsors
What You Bring:
Bachelor’s degree (BA/BS) or equivalent (emphasis in management or related discipline preferred)
PMP certification or equivalent (e.g., PRINCE2) preferred
Minimum of 7 years of project management experience, preferably within medical device, life sciences, pharmaceutical, or other regulated industry
Experience with quality systems, regulatory compliance, product development, or manufacturing projects preferred
Strong knowledge of project management methodologies and tools (Microsoft Project, SharePoint, Visio, etc.)
Working knowledge of Quality Management Systems (QMS) and global regulatory requirements (FDA, ISO 13485, MDR, etc.)
Understanding of design controls, change management, CAPA, complaint handling, risk management, and product lifecycle processes
Excellent planning, organization, prioritization, interpersonal, facilitation, communication, and presentation skills
Demonstrated ability to influence without direct authority and drive consensus
Strong problem-solving, critical thinking, and decision-making skills
Ability to manage multiple priorities in a fast-paced, changing environment
Why VB Spine? We believe in growing talent from within. At VB Spine, join a high-performing team where you’ll lead critical RAQA projects that strengthen compliance, quality, and product lifecycle excellence — supporting the delivery of innovative spinal solutions that improve patient lives.
Compensation: Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $125,000.00 - $145,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, skillset, and market conditions.
Benefits include:
Comprehensive health, dental, and vision insurance
401(k) with company match
Paid time off (PTO) and holidays
Ongoing training and professional development opportunities
Opportunity to grow within a fast-paced, dynamic company
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