R&D Project Management Associate Director – GE, Post-Market & Lifecycle Management

About Us

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

A Brief Overview

As an R&D Project Management Associate Director, you will lead cross-functional project management activities supporting geographic expansion programs, lifecycle Design and Development File (DDF) maintenance, post-launch maintenance, Medical Affairs PMO projects and post-market clinical study commitments for commercialized products. This role reports to the Head of PMO for Merz Aesthetics and works within the PMO organization in Raleigh, North Carolina. This role ensures marketed products remain compliant, supported by appropriate design control documentation, and positioned for growth through geographic registrations and indication expansions. The individual serves as a strategic project-management lead and best-practice resource across Regulatory Affairs, Clinical, Quality, Global Technical Operations (GTOps), and Commercial teams to drive execution of post-launch R&D initiatives.

What You Will Do

• Geographic Expansion Project Management:
  • Lead strategic planning and execution of complex geographic expansion projects for commercialized products, including prioritizing project tasks, identifying the critical path, evaluating cross-functional dependencies, removing any obstacles or barriers, and resolving issues or conflicts to progress the project.
  • Lead and coordinate cross-functional feasibility assessments for new market registrations, indication expansions, and registration renewals; integrate regulatory, clinical, quality, technical, commercial, timeline resource, and risk considerations into recommendations for governance and decision-making.
  • Lead project-team governance, including setting decision-oriented agendas, facilitating resolution of cross-functional issues, documenting key decisions and accountabilities, and maintaining integrated project timelines, resource plans, risk registers, and other required project documentation.
  • Effectively lead, guide, and manage a team of cross functional resources to deliver the set project milestones supporting the required regulatory submissions and launches, including negotiating priorities, resource commitments, and corrective actions across functions.
  • Facilitate cross-functional alignment between regional, country, and global stakeholders throughout the expansion process by communicating complex issues, anticipating objections, reconciling competing priorities, and building consensus around recommended approaches.
  • Monitor project progress and independently resolve issues within the role's authority, escalate only the most complex, high-risk or strategically significant issues that may impact submission or approval or launch timelines.
  • Anticipate and manage project risks and issues, evaluate broader cross-functional implications, and develop and provide innovative mitigation, contingency, and corrective action strategies where precedent may be limited.
  • Prepare governance materials and present evidence-based recommendations, options, trade-offs, resource implications, and risk scenarios for leadership review and approval.
• Lifecycle DDF Management:
  • Lead and coordinate R&D-impacted lifecycle design control activities for marketed products, establishing integrated priorities, governance, and execution plans across affected functions.
  • Direct the cross-functional planning and governance of Design and Development Files updates resulting from post-market product changes, geographic expansions, post-market commitments, and regulatory changes, ensuring dependencies and business implications are identified and addressed.
  • Establish and monitor the integrated project approach required to ensure design control documentation remains complete, traceable, compliant, and inspection ready. Identify systemic gaps and recommend corrective or preventive improvements.
  • Partner with Quality, Regulatory Affairs, and GTOps to ensure appropriate change control and document approvals.
  • Provide project-management leadership for the preparation and maintenance of technical documentation required for ongoing market authorization, resolving cross-functional dependencies and risks that could affect continued product availability or compliance.
• Post-Market Projects & Clinical Study Management:
  • Lead project management activities associated with post-market projects, clinical studies and post-approval commitments, translating regulatory-authority requirements into integrated execution, resource, risk, and governance plans.
  • Develop integrated study timelines and track critical milestones, deliverables, and action items.
  • Lead communication and alignment between Clinical Affairs, Regulatory Affairs, Medical Affairs, and external partners, ensuring complex issues, competing priorities, and decision requirements are clearly understood and resolved.
  • Evaluate study progress and lead issue resolution to maintain project timelines, regulatory commitments, data integrity, and applicable product or business objectives.
  • Ensure study outcomes, reports, and supporting documentation are incorporated into applicable product files and regulatory documentation.
  • Maintain portfolio-level visibility of post-market commitments and provide leadership and governance teams with analysis of status updates, emerging risks, resource implications, decision requirements, and recommended corrective actions.
  • Define, monitor, and manage project budgets, including quarterly forecasting and monthly budget reconciliation and reporting. Evaluate financial risks and trade-offs and recommend resource adjustments to support project and portfolio priorities.
• Post-Launch Maintenance:
  • Lead cross-functional planning and execution of post-launch maintenance activities for commercialized products.
  • Ensure alignment of maintenance priorities, resources, and decision requirements across Regulatory Affairs, Quality, GTOps, Clinical, Safety and Commercial functions.
  • Monitor execution of maintenance initiatives and proactively manage risks, dependencies, and resource requirements.
  • Provide cross-functional leadership and best-practice guidance for evaluating and implementing product improvements, manufacturing changes, labeling updates, and risk mitigation activities. Interpret internal and external requirements and recommend appropriate execution strategies.
  • Provide governance oversight, portfolio visibility, and leadership reporting for post-launch maintenance activities.
• Further Tasks:
  • Lead ad-hoc projects and/or multidisciplinary task forces for ongoing development and/or refining of processes as needed

Minimum Requirements

• Bachelor's Degree in Life Science, Engineering, Project Management, or related discipline
• 7+ years of experience product development of complex and/or highly regulated products, with the majority of experience in medical device and/or pharmaceutical product development
• 5+ years in the role of Project Manager/Leader of multiple high-impact cross-functional projects through commercial launch

Preferred Qualifications

• Master's Degree Life Science or related discipline

Technical & Functional Skills

• Thorough understanding of Project Management Office practices, principles, governance, and tools for medical device, drug or other highly regulated product development and lifecycle management projects
• Advanced skills in MS Office (Excel, Outlook, PowerPoint, Word, etc.), proficient in MS Project and comfort with a large variety of digital communication tools and AV equipment
• Advanced working knowledge of Design Control, ISO 13485, ISO 14971, change control, post-market requirements, and other applicable standards with the ability to interpret their implications for cross-functional project execution
• Experience working with class III medical devices and class II electro-mechanical devices
• Proven experience independently leading multiple complex, cross-functional projects or workstreams concurrently while managing interdependencies, risks, resources, and competing priorities
• Advanced analytical capability, including the ability to integrate information from multiple sources, evaluate business and regulatory implications, develop innovative solutions, and present evidence-based recommendations to leadership and governance bodies
• Demonstrated proficiency managing rapidly changing priorities and aggressive timelines
• Good knowledge of SharePoint site management
• Flowchart software experience, such as with MS Visio
• Excellent written and verbal communication and interpersonal skills
• Demonstrated ability to lead through influence in a matrix environment, communicate complex or sensitive matters clearly, anticipate objections, resolve conflict, and build consensus among senior cross-functional stakeholders
• Demonstrated ability to effectively represent project and program recommendations with senior internal stakeholders, governance bodies, regulatory-facing functions, and external partners
• Demonstrated ability to interpret internal and external regulatory, clinical, quality, technical, operational, and commercial issues and translate them into integrated project strategies and recommendations
• Ability to exercise sound judgment and independently resolve complex problems, seeking guidance only in the most complex or high-risk situations