Sr. Project Manager, RAQA

VB Spine
  • Allendale, Michigan
    3 days ago

    Job Description

    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

    Numbers & Facts

    LocationAllendale, Michigan
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    Skills

    • Best Practicesunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Budget Forecastingunmatched
    • Budgetingunmatched
    • Calendar Managementunmatched
    • Change Controlunmatched
    • Change Managementunmatched
    • Coachingunmatched
    • Communication Skillsunmatched
    • Compensation Managementunmatched
    • Compensation and Benefitsunmatched
    • Contingency Plansunmatched
    • Continuous Improvementunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cross-Functionalunmatched
    • Documentation Planunmatched
    • Establish Prioritiesunmatched
    • FDA Requirementsunmatched
    • Financeunmatched
    • Financial Projectionsunmatched
    • ISO (International Organization for Standardization)unmatched
    • Interpersonal Skillsunmatched
    • Leadershipunmatched
    • Manufacturingunmatched
    • Marketingunmatched
    • Medical Equipmentunmatched
    • Mentoringunmatched
    • Microsoft Projectunmatched
    • Microsoft SharePointunmatched
    • Microsoft Visiounmatched
    • Microsoft Visual Basicunmatched
    • Multitaskingunmatched
    • PRINCE2unmatched
    • Patient Careunmatched
    • Policy Implementationunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Product Developmentunmatched
    • Product Lifecycleunmatched
    • Product Lifecycle Managementunmatched
    • Project Management Professional (PMP)unmatched
    • Project Management Softwareunmatched
    • Project Planningunmatched
    • Project Scheduleunmatched
    • Project Trackingunmatched
    • Project/Program Managementunmatched
    • Quality Assuranceunmatched
    • Quality Managementunmatched
    • Quality System Requirements (QSR)unmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Research & Development (R&D)unmatched
    • Risk Analysisunmatched
    • Risk Managementunmatched
    • Supply Chain Operationsunmatched

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