Regulatory Affairs Engineer

Location: 

IL

Job ID:  52843
Category:  Manufacturing & 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.

 

As a member of the Regulatory Affairs Team, the Sr. Regulatory Affairs Materials Engineer will play a crucial role in ensuring compliance with regulatory standards and managing projects related to regulatory affairs. You will collaborate with cross-functional teams, including R&D, Product, Engineering and Legal, to ensure the successful development, registration, and maintenance of our products in compliance with relevant regulations and standards. Relevant standards include, but not limited to: REACH, SVHC, TSCA, Prop 65, K-REACH, UK-REACH, RoHS, chemical emissions, and transportation of chemicals.

 

Essential Duties and Responsibilities include the following:

  • Stay updated on global regulatory requirements, standards, and guidelines related to materials engineering WW.
  • Develop and implement regulatory strategies and plans to ensure compliance with applicable regulations.
  • Review and approve technical documentation, such as Material Safety Data Sheets (MSDS), to ensure compliance with regulatory requirements.
  • Prepare and submit regulatory dossiers, including pre-market notifications, product registrations, and technical files, to regulatory authorities.
  • Collaborate with cross-functional teams to gather necessary information and documentation for regulatory submissions.
  • Communicate with regulatory agencies and respond to inquiries, requests for additional information, and regulatory queries.
  • Maintain project documentation, records, and databases to ensure accurate and up-to-date information.
  • Collaborate with R&D and WW business units to provide regulatory guidance and support during product development and the whole product lifecycle.
  • Participate in cross-functional meetings to provide regulatory updates and support decision-making processes.
  • Coordinate with external laboratories for testing and analysis of materials and provide support during regulatory inspections.
  • Familiarity with Hazard Communication (HAZCom) standards and regulations (chemical classification) is a plus.

 

Essential Education, Skills and Experience:

  • Bachelor's or Master's degree in Chemistry, Chemical Engineering, Materials Engineering, or a related field.
  • 3-5 years industry experience in materials compliance is required.
  • 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., printing industry, chemicals).
  • Effective communication skills, both written and verbal, with the ability to collaborate with cross-functional teams.
  • Excellent written and verbal communication skills in English to effectively interact with internal teams and regulatory authorities.
  • Ability to collaborate effectively and work harmoniously with cross-functional teams and stakeholders.
  • Familiarity with regulatory submission processes and documentation requirements.
  • Experience with regulatory software and tools is a plus.
  • Experience in formulation development is a plus.

 

What​ ​you​ ​will​ ​be​ ​part​ ​of: