Move Fast and Make Things!
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 continuously seek contributors who demonstrate outstanding integrity, intelligence, accountability, and a passion for learning. We celebrate diversity and are committed to creating an inclusive environment for all employees.
VulcanForms is hiring a Regulatory Affairs and CE Marking Specialist for our Burlington, MA location.
VulcanForms is looking for a Regulatory Affairs and CE Marking Specialist located at our Burlington, MA facility. The main objective in this role will be to lead the regulatory compliance efforts for all our products and service. The ideal candidate will have experience performing and coordinating the actions required to obtain a CE mark and REACH compliance on large manufacturing systems. You will work with other disciplines to get 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 effort 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.
- 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 the potential risk.
- Provide the New Product Development and Manufacturing Engineering Teams guidance for tests to meet the product’s specifications
- Participate in 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 expenses, 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.
- 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
- Authorized to work within the U.S. without restrictions or sponsorship now or in the future (U.S. Citizen or lawful Permanent Resident of the U.S. (U.S. green card holder))
- Strong sense of ownership
- 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
- Detail-oriented and experience with clear, organized documentation and task management
- Team player with excellent communication skills
- Excited about taking on new challenges in the metal additive manufacturing industry and working in a fast-paced startup environment
- Self-motivated, hands-on, practical mindset, and capable of setting and reaching ambitious goals
- Medical, dental, vision, and life insurance available to you starting on your first day of employment
- Generous time off package including vacation PTO, sick PTO, and 11 company-paid federal holidays.
- Flexible work schedule
- 401(k) with company match and stock options.
To apply for this job please visit apply.workable.com.