Note: The job is a remote job and is open to candidates in USA. VB Spine is a medical technology company focused on innovative spinal solutions and improved patient outcomes. The Sr. Project Manager, RAQA will lead complex cross-functional projects involving regulatory compliance, quality systems, product lifecycle management, and critical business objectives. The role manages project scope, schedules, budgets, risks, stakeholders, and compliance initiatives while supporting continuous improvement and mentoring project team members.
Responsibilities
- 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
Skills
- Bachelor's degree (BA/BS) or equivalent
- Minimum of 7 years of project management experience
- 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
- 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
Benefits
- 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
- Potential for bonuses and incentives
Company Overview