Join a well respected leader in wet wipe manufacturing as Director, Regulatory/Product Stewardship. Position can be located in either Springdale, AR or Sheboygan, WI.
In this newly created position, you will join our Global Quality leadership team and manage all aspects of product stewardship including global regulatory compliance. Your expertise and experience will provide regulatory guidance on Rockline’s product compliance, development and marketing programs as well as any quality issues which may arise. This position will lead a team of compliance professionals who help support regulatory and labeling compliance for the organization and manage the registration, submission and filing processes of compliance documentation. The Director, Product Stewardship will further enhance product safety and compliance by establishing and maintaining a new Product Stewardship program for Rockline.
Functions of the position include:
Serve as the primary regulatory affairs resource for Rockline, providing strategic support to development, commercialization and compliance teams.
Work collaboratively with legal (internal or external), customers, suppliers and non-governmental agencies.
Effectively translates new and current global regulatory requirements and industry standards into easily understandable guidance for the organization.
Accountable and responsible for knowing and understanding Global, US, EU, UK and AU Federal & state (US only) regulations and pending regulations or changes and customer document requirements as they apply to Rockline products as well as related product safety and compliance regulations.
Lead the Global QA Compliance team which includes having oversight of label compliance, quality system management, internal auditing, recalls, management reviews, non conformance, and compliance improvement programs.
Responsible for overseeing all regulated product registrations EPA, FDA (OTC and UDI), AUSTRALIA TGA, EU & UK BPR along with new and existing foreign country registrations.
Accountable and responsible for raw material and product certifications (RSPO, FSC, PEFC, Nordic Swan, CARB, Prop 65, Leaping Bunny, NEA, etc.).
Obtain and retain all required information (under separate NDA for product safety and regulatory purposes) for all raw material suppliers to assure compliance and approve all changes in composition, process, new facilities, etc. globally.
Hire, mentor, and lead direct reports.
Requirements of the position include:
A minimum of a BS degree (Masters preferred) in a scientific discipline* and experience serving in a product stewardship role will be required. *BS/MS in Toxicology or MS in Regulatory Science/Regulatory Affairs will be a definite plus.
A minimum of 10 years related experience advising on FDA , EPA and other globally regulated products required.
A minimum of 5 years of management experience required. Experience having direct reports.
Possess a thorough understanding of US FDA, EU and Canadian OTC drug, medical device, cosmetic and consumer good regulations as well as having knowledge of Global regulations will be essential.
Able to counsel the organization concerning product stewardship, and regulatory matters.
Experience in effectively interacting and communicating with different regulatory bodies, industry consultants and influential customers globally.
Must have the ability to make decisions within general guidelines and communicate to senior management.
Must be capable of working in a matrix management structure and have the ability to influence work process changes to functions without direct reporting relationships.
Experience in disinfectant and germicidal registrations, submitting 510k applications and wet wipes’ industry is a strong plus.
Must have effective project management skills; highly motivated, organized and have the ability to prioritize job functions with attention to detail and deliver results within required timeframes.
Travel between 15-25% will be required, domestic and international
Employer will assist with relocation costs.
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About Rockline Industries
People who make it right! Inspiring customer loyalty by turning ideas into convenience products delivering superior value. We are one of the world’s largest manufacturers of coffee filters, consumer, health care, industrial and institutional wet wipes.