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Director - R&D

Job Code - EC0817

Sr. Regulatory Compliance Engineer St.Paul MN
The Sr. Regulatory Compliance Engineer monitors business activities for compliance with applicable rules and regulations and ensures compliance to external customer regulatory compliance requests. Assists in the development and implementation of compliance programs and data management for the organization. Responds to inquiries from customers and subsidiaries on a global scale and completes required compliance documentation. Ensures operating manuals and procedural documents stay current when regulations change.

1) Creates and establishes a robust infrastructure within our ERP system to track, monitor, and alert the proper teams of Regulatory Compliance Changes/Updates.
2) Establish risk mitigation planning process and standardized communication policy within organization for compliant materials and high-risk items that are under review.
3) Identify industry/enterprise trends and emerging risks to enhance the risk and control plan.
4) Develop and maintain accurate compliance reports.
5) Provide accurate interpretation of regulations.
6) Communicate directly with customers both internally and externally to provide quick responses to incoming regulatory compliance requests.
7) Gain 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.
8) Collaborate with strategic sourcing to establish relationships with our supplier base to procure compliance information and material documentation in a timely manner.
9) Ability to perform calculations of SVHC in products to help customers understand if they are under or over limit within their full product design.
10) Self-Driven to continuously learn about current and expanding regulations
11) Ownership of technical declarations within customer and 3rd party compliance portals.
12) Work with subsidiaries as necessary to provide joint support on regulatory submissions.
13) Partner with QC Compliance Engineering Department to ensure the Material Selection Guide (MSG) stays up to date for design engineering use.
14) Maintains all regulatory records, process documentation, and ERP system information and updates.
15) Educate departments on new regulations and their effective dates.
16) Lead and mentor the Regulatory team on regulations, best practices, and continuous improvements
17) Support engineering on design changes needed to meet and maintain compliance.
18) Support regulatory investigations and respective corrective/preventative actions.
19) Represents NWI for verification & validation of regulatory compliance documentation and processes controls during audits.
Requirements:
Candidate should be educated on the following directives, standards, and ISO QMS as a min:
1) EU MDR Regulations & Reporting
2) EU Waste Frame Directive (SCIP Database)
3) REACH / RoHS / RoHS3 / China RoHS
4) Proposition 65
5) TSCA
6) TSE/BSE Risk Analysis
7) TBA/TCA/ISPM 15
8) Dodd – Frank Act on Conflict Minerals (i.e. CMRT & CRT)
9) ISO 9000 / ISO 13485 / AS9100
10) Basic Understanding of Product Compliance (i.e. UL/CSA)
Candidate should have a high level of experience creating the following document types:
1) IMDS (i.e. materials breakdown by construction level, substance ID, & amounts in the product) a plus
2) Product SDS / TDS
3) Compliance Declarations
4) Dossiers
Candidate should exhibit the following skillsets:
1) Subject matter expert on Regulatory Compliance topics
2) Ability to lead meetings with and answer questions directly from supplier’s regulatory departments
3) High level of organization with the ability to own and build the infrastructure for the regulatory data
4) Materials knowledge (i.e. polymers/plastics, metals/metal alloys/metal coatings, polymer tapes, etc.)
5) Experience with wire and cable, cable assemblies, connectors, or cable components a plus
6) Excellent verbal and written communication skills, with ability to communicate to all levels
7) Sense of Urgency for Customer Responses and Workload
8) Attention to Fine Details
9) Strong sense of Accountability
10) English Proficiency Level: C1 (Advanced)
Supervisory Responsibility:
This position does not have supervisory responsibilities.
Required Education:
Min. Degree in Regulatory Compliance, Engineering, Polymers, or Regulatory Compliance Certificate with 10+ years of equivocal industry experience.
Required Experience:
1) Direct experience with Regulatory Compliance Risk Management.
2) Expert level of experience with Microsoft Excel to use functionality in analyze big data.
3) 5+ years of direct regulatory compliance experience within a manufacturing environment (i.e. polymer compounding, medical device or assemblies, automotive, aerospace, industrial)
4) Extensive time and project management skills to set and deliver on priorities and deadlines

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