Senior Regulatory Compliance Specialist

Working at the intersection of hardware, software and molecular science, we are committed to delivering on the promise of 3D printing, enabling commercial customers to go beyond basic prototyping to 3D manufacturing. Our company is built on the idea that diverse fields of study must come together to solve intractable problems. We have grand ambitions to create technology that will influence industry around the world. You will be joining a diverse team with a vibrant culture, where team success is as important as celebrating individual contributions. Help us change the world and we will help you change yours.

As a Regulatory Specialist, you will be responsible for ensuring compliance of Carbon’s resin and hardware products with applicable chemical regulations and standards. You will play a lead  role in ensuring Carbon is meeting regulatory requirements related to the development, production, import, export, and distribution of its products.

Your primary focus will be on development, commercialization and enabling supply chains for new resin products by researching, interpreting, and implementing regulations and standards. You will also be responsible for developing internal programs or standard processes that support the regulatory function, as needed.

NOTE: This is a temporary role (approximately 6 to 9 months); and the office schedule preference is at least 3 days a week in our Redwood City location, but 5 days a week is preferred. 

Responsibilities:

• Regulatory Compliance: 
• Stay up-to-date with relevant local, national, and international chemical regulations, such as REACH, CLP, TSCA, GHS, Prop 65, CEPA (Canada), CSCL/ENCS & ISHL (Japan), NICNAS (Australia), Order Number 12 (China), ChemO (Switzerland), TCCSCA (Taiwan), and other applicable regulatory frameworks. 
• Interpret regulatory and apply chemical regulatory requirements and communicate their impact on product development, product commercialization, labeling, storage, transportation, and disposal practices.
• Monitor evolving regulatory requirements and standards in customer regions, assess their potential impact on Carbon’s operations and recommend necessary actions to maintain compliance.
• Ensure Carbon’s products and processes are in compliance with these regulations.
• Chemical Registrations: 
• Prepare, submit and maintain necessary regulatory documentation to enable new product introductions, including substance registrations and notifications to relevant regulatory bodies within specified deadlines.
• Prepare regulatory declarations (REACH, Prop 65, CE/ UKCA, etc.) for Carbon products.
• Substance Reporting and Documentation:
• Conduct regulatory assessments for new formulations and raw materials, identifying potential issues and providing recommendations to mitigate risks.
• Perform inventory searches and volume tracking of applicable substances and reporting to applicable regulatory agencies or consulting bodies.
• Cross Functional Support:
• Partner with R&D teams during the product development process to provide guidance on regulatory constraints, ensuring product compliance from concept to commercialization.
• Collaborate with Operation teams, such as manufacturing, quality control, legal, and supply chain, to provide expert advice and drive strategy for scalable operations and regulatory compliance.
• Communicate regulatory strategies to minimize supply chain impact.
• Develop and maintain Regulatory infrastructure:
• Establish and maintain compliant regulatory infrastructure by understanding existing issues and potential issues that may arise. 
• Developing processes and systems and documenting appropriate policies, procedures and guidance documents.
• Minimize regulatory risks and maintain Carbon’s reputation with customers and regulators.
• Regulatory Audits and Inspections:
• Prepare for and participate in regulatory audits and inspections to demonstrate compliance with applicable chemical regulations.
• Lead investigations to address findings or non-compliance issues and implement corrective actions.
• Conduct regulatory audits for critical material manufacturers and suppliers.
• Product SDS Documentation and Hazard Classification: 
• Determine the proper classification and hazard assessment of chemicals based on GHS and other applicable regulatory standards. 
• Identify the testing required to determine the shipping classification of chemical products. 
• Help review SDSs, labels and product manuals for Carbon products for accuracy and consistency.
• Training and Awareness: 
• Conduct training sessions and create educational materials to raise awareness within Carbon about chemical regulations, best practices, and potential risks associated with non-compliance.
• Manage Regulatory Cost Center:
• Predict and manage regulatory department cost and budget.
• Industry Engagement:
• Establish and maintain relationships with regulatory agencies, industry associations, critical raw material manufacturers and suppliers, regulatory consultants and service providers.
• Represent Carbon in industry trade groups and associations in discussions related to chemical regulations.

 
Requirements:

• Bachelor's degree or higher in chemistry, chemical engineering, environmental science, or a related field. Advanced degrees or certifications in regulatory affairs are desirable.
• 5-10 years of experience in the field of chemical regulatory
• In-depth knowledge and subject matter expertise in local, national, and international chemical regulations and standards, such as TSCA, Prop 65, EU REACH, RoHS, CLP, GHS, CSCL, TSCI, etc.
• Experience in interpreting complex regulatory requirements and applying them to Carbon’s products and business processes.
• Excellent analytical, research, and problem-solving skills.
• Strong attention to detail and accuracy in documentation.
• Effective communication and interpersonal skills to collaborate with cross-functional teams and regulatory authorities.
• Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.
• Experience with regulatory audits and inspections.
• Familiarity and experience with regulatory compliance software and systems is preferred.
• Knowledge of the additive manufacturing industry is a plus.

As a Regulatory Specialist, you will play a vital role in ensuring that Carbon adheres to chemical regulations and maintains compliance with the highest ethical and safety standards. Your expertise and contributions will contribute to Carbon and its customer’s success and help protect the environment and public health.

At Carbon, we look at the person holistically and carefully consider a wide range of factors when determining salary. The compensation bracket for this position is $115,200 - $172,800. In order to maintain equitable internal pay practices, we aim to hire new employees near the midpoint of $144,000, taking into account your experience, work location, certifications, and the unique skills you bring to the role. If you are not based in our Redwood City office, the range above will be adjusted for the geographical differential associated with your actual work location.

Carbon also offers to our eligible employees a comprehensive total rewards package that includes equity, benefits, and time off programs. 

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