Regulatory Associate

Chroma Color is hiring directly! Chroma Color Corporation is a technology-leading specialty color concentrate and color master batch supplier. Chroma Color delivers critical aesthetics, technical innovations, and sustainable solutions to plastics processors and brand owners. Having made nine acquisitions Chroma Color’s growth strategy includes robust organic and inorganic growth. Chroma Color’s extensive technical leadership and manufacturing expertise, coupled with its game-changing colorant and light management technologies, have delighted customers for over 50 years.

Aids in the maintenance of the company’s regulatory systems such as ISO, NSF, Yordas and product stewardship by dispositioning all regulatory compliance requests from customers. This position has the defined responsibility in responding to regulatory inquiries from customers and internal departments as well as maintaining systems that support regulatory responses for all Chroma sites. Global Regulations include but not limited to US Food Contact (FDA), REACH compliance, California Proposition 65, EU 10/2011, Health Canada, Mercosur, China Food contact, USP 661, Carcinogen/Mutagenic/Reprotoxic, Nitrosamines, PFAS and Child Safety regulations. We make custom color so experience in plastics is REQUIRED.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

Formulates and maintains quality assurance objectives complementary to corporate policies and goals.

·        Fulfill customer regulatory requests for product compliance in a timely manner using proper documentation.

·        Research regulations to determine company alliance and compliance.

·        Work with suppliers in obtaining and organizing regulatory information.

·        Updates regulatory documentation systems such as Lisam and Yordas.

·        Supports research, and development and evaluation of new materials, vendors, equipment and processing technologies from a regulatory compliance side.

·        Develop new approaches to solve problems identified during regulatory activities.

·        Keeps management team abreast of significant issues or developments identified during regulatory activities and actions being taken to improve the situation.

·        Maintains a working knowledge of government and industry quality assurance codes and regulatory standards. Works directly with regulatory bodies to identify issues and compliance.

·        Plays an active role on regulatory management teams within the organization.

Supervisory Responsibilities: None

 Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience College graduate in field of science or at least 5 years of combination of related education and work experience in the regulatory field. Thorough understanding of key regulatory requirements such as FDA, UL, EU, ISO, Health Canada, etc for medical, pharmaceutical, food packaging and automotive type applications.

Language Skills Excellent verbal and written communication skills. Ability to read and comprehend simple instructions, short correspondence, and memos. Must be able to effectively present information in one-on-one and small group situations to customers, clients and other employees of the organization.

Mathematical Skills Knowledge of arithmetic, algebra, geometry, statistics, and their applications. Using mathematics to solve problems.

Reasoning Ability Must be able to solve problems involving a variety of concrete variables in limited standardized situations, apply common sense understanding to carry out instructions furnished in written, oral, or diagram or schedule form. Strong problem-solving capability and ability to make decisions based on skills and knowledge.

Computer Skills Must be proficient in Microsoft Office programs including Word, Excel, PowerPoint, as well as other internet-based software, must have experience working with CRM software.

Other Skills

Must be able to work independently and interact with individuals from other departments. Behavior and personal conduct must be professional and cooperative and especially courteous with visitors and customers.

Certificates, Licenses, Registrations N/A

Physical Demands While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl. The employee must be able to lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.

Work Environment The noise level in the work environment is usually quiet.

Safety Follows all company work rules, safety practices, and wearing of personal protection equipment.