Sr. Project Manager, RAQA

VB Spine, LLC•Allendale, NJ

15d•$125,000 - $145,000

About The Position

VB Spine is seeking a Sr. Project Manager, RAQA to lead medium to high complexity cross-functional RAQA projects. This role involves developing and maintaining project plans, schedules, budgets, and communication plans, while partnering with functional leaders to define project scope and objectives. The position requires coordinating activities across various departments including Regulatory Affairs, Quality Assurance, R&D, Operations, Supply Chain, Manufacturing, Clinical, Marketing, Finance, and external partners. The Sr. Project Manager will facilitate cross-functional meetings, manage decisions, action items, risks, and dependencies, and monitor project progress, communicating status and mitigation plans to stakeholders and leadership. This role also supports the implementation of new regulatory requirements, quality initiatives, remediation activities, product changes, and compliance projects, ensuring adherence to internal quality system requirements and global regulatory standards. Additionally, the role involves tracking project financials, supporting continuous improvement of project management processes, providing coaching to junior project managers, and presenting project updates to senior management.

Requirements

Bachelor’s degree (BA/BS) or equivalent (emphasis in management or related discipline preferred)
Minimum of 7 years of project management experience, preferably within medical device, life sciences, pharmaceutical, or other regulated industry
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

Nice To Haves

PMP certification or equivalent (e.g., PRINCE2) preferred
Experience with quality systems, regulatory compliance, product development, or manufacturing projects preferred

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