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Product Regulatory Compliance Manager - North Kingstown, United States - ViziRecruiter
Description
Industry:
Semiconductor Chemical Formulations
Level:
Full-Time
Location:
North Kingstown, RI
Overview
Position Summary
The Product Regulatory Manager is a key member of Fujifilm Electronic Materials U.S.A. who works with business leaders to drive product regulatory compliance while enabling growth.
This position is responsible for the product regulatory compliance of Company products marketed and sold in North America and other regions including Europe and Asia.
The position is responsible for providing internal and external customer product regulatory and safety support.Responsibilities
Chemical
Monitor changes in chemical regulatory activity and identify non-compliance issues or risks. Provide chemical management support to Manufacturing plants and laboratories. This position also functions as the Chemical Hygiene Officer for the R&D organization.
Quality Assurance
Ensure that all Company products are compliant with applicable regulations for the USA and any other regions to which they are sold.
Ensure the necessary information systems and tools are in place and maintained to meet requirements for compliance and business support.
Ensure that all department functions are documented in standard operating procedures, work instructions, and support documents including periodic document review and updates as appropriate.
AnalysisProvide regulatory review assessments during new product development. Assess business impact to new product launches related to product regulatory approvals.
Teamwork
In coordination with the business teams, develop product registration strategies in support of new product introductions. Provide guidance to affiliate regulatory teams to ensure alignment across regions.
Compliance
For the US, this includes screening for EPA compliance and preparing and submitting appropriate documentation (Low Volume Exemption (LEL) and Pre-manufacturing Notice (PMN)) to register new substances, and to monitor compliance.
Provide guidance to the business and appropriate functions on how new laws, regulations or legislation will impact our business operations and overall strategy.
MaintenanceMaintain expertise knowledge of EPA requirements for new chemical registrations and existing chemical reporting.
Globally maintain awareness of changing regulations for chemical registration and SDS's and assist in the proper registration of components for the country involved.
SupportSupport product labeling requirements. Support projects to improve overall company performance through the implementations or upgrades to the corporate SAP system.
Consulting
Recommend programs and plans and coordinate with other regions as necessary for regulatory compliance and commercial success.
Requirements
Experience
Experience or training is required in chemistry, both organic and inorganic, with the ability to perceive chemical interactions that may necessitate new substance filings; Polymer chemical background is preferred.
5-8 years of work experience in a product stewardship role. Work experience in the semiconductor materials industry. Direct managerial responsibility experience.Knowledge
Knowledge of EPA requirements for chemical registrations and reporting. Thorough knowledge of product regulations, enforcement and industry practice relevant to the chemical industry.
Skills
Basic computer programs (Excel, Word, PowerPoint, SAP) are required.
About Us
Successful semiconductor manufacturers move quickly. They demand quality and they require leading technology. For them, partnering with the right supplier is a critical decision.
With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea and Japan, local sales offices throughout the world and on site applications support, FUJIFILM Electronic Materials is prepared to supply the world's top tier semiconductor manufacturers.
FUJIFILM Electronic Materials offers a broad array of products and services used throughout the semiconductor manufacturing process.Legal Disclaimer:
FUJIFILM Electronic Materials is an equal opportunity and affirmative action employer. view full text
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