POSITION SUMMARY: The Product Compliance Specialist exists to ensure that Rockline’s products conform to the laws and regulations of the territories in which they are sold. The key to this position is to ensure products and facilities remain registered and in compliance while ensuring any associates involved in product development, marketing, and sales are aware of and abide by these regulations.
ESSENTIAL ACCOUNTABILITIES: • Submit and track product labels through the registration, renewal and/or notification process. • Register regulated products and facilities domestically and internationally. • Review product label artwork for regulatory compliance. • Research laws, regulations, regulatory bulletins, advisories, and guidance materials. • Respond and provide guidance to internal and external customer inquiries regarding US Federal, State, & local, and international regulations, and their requirements. • Maintain communication with federal and state regulatory agencies. • Submit governmental reports. • Obtain Certificates of Free Sale, cGMP, apostille, or other similar documents.
QUALIFICATION REQUIREMENTS: (To perform this job successfully, an individual must be able to perform each of the essential accountabilities satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.)
Required • Bachelor’s Degree in Regulatory Affairs or Quality Assurance, Scientific, Technical, or Legal discipline; or equivalent combination of education and experience. • 3 years prior regulatory affairs experience. • Proficiency in Microsoft Office Suite. • Strong communication skills, including the ability to communicate effectively by e-mail, by phone, and in person. • Strong organizational skills, including the ability to maintain records related to product registrations. Preferred • Regulatory affairs experience in a cosmetic, drug, or EPA registered disinfectant industry is preferred. • Previous regulatory label review and EPA product registration experience.
Rockline Industries was founded in 1976 and is headquartered in Sheboygan, Wisconsin. It is one of the world’s largest manufacturers of coffee filters and consumer, health care, industrial and institutional wet wipes. A family-owned company, Rockline has repeatedly created first-to-market product design solutions for the wet wipe consumer, and continues to provide innovative products to the nonwovens industry. Rockline employs over 2,700 people worldwide and has manufacturing facilities in Wisconsin, Arkansas, New Jersey, Tennessee*, England and South China. For more information on Rockline Industries, visit www.RocklineInd.com.
Located in Tennessee, Iatric Manufacturing Solutions, a fully owned subsidary of Rockline, is dedicated to helping foster healthy environments through the design and manufacturing of FDA-regulated wipes for use in the consumer, health care, food service, and hospitality industries. Iatric will operate out of a new 435,000-square-foot state-of-the-art FDA-registered facility in Morristown, TN. The wholly owned subsidiary was born out of the rapidly increasing demand for Rockline’s innovative wet wipes products that are designed to support healthier, sanit...ary environments and personal hygiene. The new plant will be operational beginning in 2019 and is expected to employ 250 people.