Job Location
Burlington, MA, USA

Position: Regulatory Affairs and CE Marking Specialist

Thank you for submitting your application and for your interest in working with us. We look forward to reviewing your profile and will get back to you shortly if there is a good fit.

Regulatory Affairs and CE Marking Specialist
Description

Born out of MIT, VulcanForms is commercializing the first fully scalable industrial metal additive manufacturing (AM) solution. Building the world’s most powerful and advanced metal AM system is the first step towards our vision of lights-out, highest quality metal AM mass production. We are a team of leading technology and operational experts with decades of experience in advanced manufacturing, materials, automation, and robotics. We are continuously seeking contributors who demonstrate outstanding integrity, intelligence, accountability, and a passion for learning.

Description:
VulcanForms is looking for a Regulatory Affairs and CE Marking Specialist to be located at our Burlington, MA facility. In this role, your main objective will be to lead the regulatory compliance efforts for all our products and service. The ideal candidate will have experience with performing and coordinating the efforts required to obtain a CE mark and REACH compliance on large manufacturing systems. You will work with other disciplines to obtain and organize the information needed to submit a product for CE marking. You will lead the REACH compliance process, conduct the review and organization of risk assessments, product requirements, evaluations, literature, and other materials required by the regulatory authorities. This will include following up on correspondence with the notified body. You will also prepare and work with consultants and auditors to prove our compliance with the CE and REACH requirements.

Primary Responsibilities
  • Preparation of all U.S and CE marking submissions/registration documentation
  • Preparation of all REACH compliance documentation
  • Build, lead, and manage product compliance operations program, including developing processes and procedures
  • Serve as project manager for regulatory compliance contract activities by working with consultants to ensure scheduling and project completion
  • Assist the Engineering teams in the review of all new test reports for accuracy and completeness
  • Identify areas of potential regulatory compliance jeopardy at plant, product, and research and development levels, and develop programs and procedures to reduce potential risk
  • Provide the New Product Development and Manufacturing Engineering Teams guidance for tests to meet the product’s specifications
  • Participate on New Product Development design reviews as needed to provide insight and advice on design choices as they pertain to regulatory compliance standards
  • Stay current on any changes to the regulatory compliance standards that impact VulcanForms’ products and services. Provide timely guidance to the company on the impact of the changes to new and existing designs
  • Monitor compliance costs and make recommendations to consolidate costs such as, combining certificates to reduce sustaining costs of site audits and consolidating advisory and testing services
  • Assist in the management of regulatory compliance projects at offsite compliance testing agencies
  • Serve as the primary compliance contact for OEM customers that incorporate VulcanForms’ products and services
Requirements
  • Bachelor’s degree from a four-year college or university.
  • 7+ years of experience in regulatory compliance and certification of large manufacturing systems
  • Strong hands-on knowledge of major product compliance regulatory frameworks across a global scope
  • Applicant must be authorized to work within the U.S. without restrictions (U.S. Citizen, lawful permanent resident of the U.S. (or green card holder)).
Preferred Additional Skills
  • Ability to develop and maintain effective relationships and communications with internal and external partners
  • Ability to rapidly assimilate and achieve a strong understanding and familiarity with other material compliance regulations / directives that become applicable
  • Strong written and verbal communication skills
  • Detail-oriented and experience with clear, organized documentation and task management
  • Self-motivated, capable of setting and reaching ambitious goals