Stratasys Sr Regulatory Affairs Materials Engineer 

United States, Minnesota 

953856825

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.

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 astheofficial 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
• Experience with regulatory software and tools is a plus
• Experience in formulation development is a plus
• Familiarity with Hazard Communication (HAZCom) standards and regulations (chemical classification) is a plus
• Experience as a US agent and importer (facilitating communication between the FDA and the foreign manufacturer) is a plus

What you will be part of:

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• Our Culture and Values-
• Our Sustainability “3D Printing a Better Tomorrow”-
• Our Locations-
• Check out our Video-

For this position, the typical annual starting base salary is from $103,783 to $134,064, which does not include variable incentive pay. This range represents a good faith estimate for this position. Your individual base pay will depend on your skills, qualifications, geographical location, and/or experiences.

In addition to a competitive salary, we offer a comprehensive total rewards package (e.g., Medical, Dental & Vision, Health Savings Accounts, Mental Health Resources etc.), recognition programs, employee stock purchase plan, and 401(k) with company match.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Stratasys will provide reasonable accommodations for qualified individuals with disabilities. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.