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