Sr. Regulatory Affairs Materials Engineer

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.

The Sr. Regulatory Affairs Materials Engineer will ensure compliance with regulatory standards and oversee projects related to regulatory affairs. This role involves collaborating with R&D, Product, Engineering, and Legal teams to support the development, registration, and maintenance of products in line with regulations such as REACH, SVHC, TSCA, Prop 65, RoHS, chemical emissions, medical certifications, food contact approvals, and chemical transportation.

What you will be doing:

• Collaborate with R&D and global business units to provide regulatory guidance and support during product development and the whole product lifecycle
• Review and approve technical documentation, such as Material Safety Data Sheets (MSDS), to ensure compliance with regulatory requirements
• Maintain project documentation, records, and databases to ensure accurate and up-to-date information
• Participate in cross-functional meetings to provide regulatory updates and support decision-making processes
• Develop and implement regulatory strategies and plans to ensure compliance with applicable regulations
• Stay updated on global regulatory requirements, standards, and guidelines related to materials engineering globally
• Communicate with regulatory agencies and respond to inquiries, requests for additional information, and regulatory queries
• Collaborate with cross-functional teams to gather necessary information and documentation for regulatory submissions
• Prepare and submit regulatory dossiers, including pre-market notifications, product registrations, and technical files, to regulatory authorities
• Act as the official US agent and importer for the company, facilitating communication between the FDA and the foreign manufacturer
• Follow all company safety policies and procedures
• Attend all required company training
• Demonstrate commitments to Stratasys Behaviors by leading, acting, and modeling these values
• Other responsibilities as assigned by the department or manager

Must have for this role:

• Bachelor’s degree in Chemistry, Chemical Engineering, Materials Engineering or other related field
• 5 years industry experience in materials compliance
• Solid understanding of materials science and engineering principles
• Strong knowledge of global chemical regulations and standards
• Previous experience in regulatory affairs, or materials engineering within a regulated industry (e.g., medical devices, pharmaceuticals, chemicals)

Nice to have for this role:

• Familiarity with regulatory submission processes and documentation requirements