Project Manager - Regulatory Operations

Stratasys is a world leader in 3D printing!

Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products and healthcare. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain. The world’s leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care.

We are seeking a Project Manager with chemistry or technical regulatory background to support the operational, analytical, and cross‑functional activities of the Regulatory Affairs team.

In this role, the Project Manager will lead the planning, coordination, and execution of regulatory and cross‑departmental initiatives, ensuring alignment with organizational priorities and timelines. The position requires strong project management expertise and excellent communication skills. Responsibilities include coordinating team workflows, preparing project documentation and presentations, and facilitating effective collaboration with internal stakeholders, external partners, and regulatory service providers.

Key Responsibilities

• Develop, maintain, and monitor project plans, timelines, milestones, and deliverables.
• Coordinate and collaborate with R&D, Operations, Engineering, Legal, and other teams across the organization.
• Lead material compliance projects, including planning and execution.
• Track team progress, ensure follow‑up on open items, and help remove obstacles.
• Assist in annual and ongoing budget planning and management.
• Monitor, interact, report, and provide support to local R&D and Engineering regarding compliance matters, enforcement actions, remedial activities, and regulatory requirements.
• Manage global initiatives, ensuring alignment and effective utilization of cross‑functional resources.
• Work with advisory services and manage regulatory subcontractors.
• Assess local and regional compliance requirements and implement programs/systems to ensure regulatory compliance.
• Gather strategic intelligence on evolving product regulations, advise management, and drive implementation of required compliance actions.
• Generate or collect necessary documentation to support certifications and coordinate submissions to certifying laboratories/organizations.
• Evaluate regulatory trends and revisions, and work with functional departments to proactively adjust processes to avoid certification disruptions.
• Develop workflows, protocols, and tactical direction to support standardization and administration of product compliance programs.
• Prepare clear, professional presentations and reports for internal and external audiences.
  
  

• Degree in Chemistry, Chemical Engineering, or related field
• minimum of 5 years of experience with cross-organization project management
• Experience in regulatory affairs project management – a plus
• Understanding of chemical hazard classification – a plus
• Excellent written and verbal communication skills.
• Ability to manage multiple tasks, meet deadlines, and handle changing priorities.
• High level of ownership, accountability, and independence.
• Strong interpersonal skills and the ability to collaborate with diverse global teams.
• Attention to detail with a structured, methodical working approach.
• Proactive problem‑solver with the ability to anticipate needs.
• Team-oriented with a positive, supportive approach.
• Fluent English (written and verbal).