About the Role
The Regulatory Compliance Specialist monitors business activities for compliance with applicable rules and regulations and ensures compliance with external customer regulatory compliance requests.
Key Activities
Creates and establishes a robust infrastructure within our ERP system to track, monitor, and alert the proper teams of Regulatory Compliance Changes/Updates.
Establish a risk mitigation planning process and a standardized communication policy within the organization for compliant materials and high-risk items that are under review.
Coordinates with the North American Regulatory Compliance Team.
Identify industry/enterprise trends and emerging risks to enhance the risk and control plan.
Develop and maintain accurate compliance reports in conjunction with the North American team.
Provide accurate interpretation of regulations.
Communicate directly with customers both internally and externally to provide quick responses to incoming regulatory compliance requests.
Gain an understanding of our materials and products to have a technical understanding of the regulatory impacts of materials being proposed to be added to the SVHC lists.
Collaborate with strategic sourcing to establish relationships with our supplier base to procure compliance information and material documentation in a timely manner.
Ability to perform calculations of SVHC in products to help customers understand if they are under or over the limit within their full product design.
Self-driven to continuously learn about current and expanding regulations as well as new ones on the horizon, to represent the company's position and respond accordingly to requests.
Supports company technical declarations within customer and 3rd party compliance portals.
Work with company subsidiaries as necessary to provide joint support on regulatory submissions.
Partner with QC Compliance Engineering Department to ensure the Material Selection Guide (MSG) stays up to date for design engineering use.
Maintains all regulatory records, process documentation, and ERP system information and updates.
Preferred Skills
Previous project management experience, including leading a team and/or all or part of a project.
Demonstrated ability to work independently with little to no supervision.
Agile, QuickBase, SharePoint, or other database utilization and management experience.
Education and Experience
Direct experience with Regulatory Compliance Risk Management.
Expert level of experience with Microsoft Excel to use functionality in analyzing big data.
3+ years of direct regulatory compliance experience within a manufacturing environment (i.e., polymer compounding, medical device or assemblies, automotive, aerospace, industrial) or equivalent education.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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