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Product Regulatory Engineer

Job Details

Experienced
Franklin, KY
Full Time
4 Year Degree/Bachelors
Product Management

Description

We are seeking a motivated and detail-oriented professional to join our team as a Product Regulatory Affairs Engineer.  In this role, you will play a vital part in supporting our operational goals while contributing to a collaborative and high-performance culture. The ideal candidate brings strong problem-solving skills, adaptability, and a drive to learn and grow within a dynamic environment. This role will ensure that Vybond products are safe for their intended end uses and fulfill relevant regulatory compliance requirements.  The scope is inclusive of product safety and regulatory guidance for raw material selection, product end use(s), reclaim and disposal.

Key Responsibilities:

  • Ensure adherence to strategic programs for Product Safety and Regulatory Affairs
  • Maintain and manage product safety and regulatory information in an efficient and confidential manner. 
  • Gather product safety information from suppliers regarding raw materials used in products to facilitate timely response to customer inquiries.
  • Provide feedback and information to fulfill customer regulatory needs.  Act as a primary interface for product safety and regulatory affairs. 
  • Maintain and manage the regulatory and product safety files, including confidential information.
  • Meet the regulatory needs of Vybond’s internal and external customers including: obtaining product safety information from suppliers; preparation of product Safety Data Sheet (SDS), Article Information Sheet (AIS) or Article Exemption letters; preparation of product regulatory compliance letters which address customer’s needs and response to product regulatory questionnaires.
  • Prepare/coordinate Product Safety documentation as needed such as migration studies, biocompatibility testing etc., supporting internal and external requests.
  • Develop and maintain regulatory databases as needed.
  • Develop expertise and knowledge regarding specialized testing associated with product safety, food contact compliance statements and other regulatory requirements.
  • Provide accurate and timely information to internal and external customers.
  • Maintain and support the REACH, RoHS, Prop 65, Conflict Minerals compliance for Vybond products.
  • Actively participate in gathering knowledge of new regulations affecting Vybond products.
  • Use of ERP and other tools that holds product safety information including Bill-of-Materials, SDS, Product Safety testing, new chemical review of raw materials proposed for use.
  • Use of the Sphera Solutions Intelligent Authoring tool to create SDS/AIS and regulatory declarations.

Other Responsibilities:

  • Database administration and maintenance of new or completed regulatory requests
  • Consolidation and organization of vendor certifications
  • Supplier interaction, requests and follow up
  • Refine processes and procedures for issuance of product regulatory certifications
  • Conduct research as needed for product compliance requirements
  • Strategic problem solving and provide input for policy development of Safety Data Sheet (RDS) and/or Product Stewardship Information (PSI) documents
  • Other duties as may be required

Qualifications

  • Bachelor’s degree in chemistry, engineering, or a related field
  • 5 + years of relevant experience in regulatory affairs or other related experience.
  • Knowledge of REACH, RoHS, Prop 65, and other applicable product regulations.
  • Understanding of audit and testing practices applicable to regulatory compliance.
  • Ability to use custom regulatory tools, standard office-based productivity tools (i.e. MS Office) and ERP tools.
  • Exceptional organizational skills and attention to detail.
  • Strong analytical and problem-solving abilities.
  • Ability and accountability to work independently and as part of a team.
  • Excellent communication and interpersonal skills to manage relationships across departments and with external partners.
  • Proven ability to handle complex compliance issues and meet strict deadlines.
  • Acquire certifications and training in product safety and regulatory requirements as appropriate
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