Regulatory Compliance Specialist

Summary/Objective:

 The Regulatory Compliance Specialist 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. Provides daily support and guidance to the LEMO USA and Northwire Regulatory Compliance Team. 

Essential Functions:

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. Coordinates with the North American Regulatory Compliance Team.
4. Identify industry/enterprise trends and emerging risks to enhance the risk and control plan.
5. Develop and maintain accurate compliance reports in conjunction with the North American team.
6. Provide accurate interpretation of regulations.
7. Communicate directly with customers both internally and externally to provide quick responses to incoming regulatory compliance requests.
8. 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.
9. Collaborate with strategic sourcing to establish relationships with our supplier base to procure compliance information and material documentation in a timely manner.
10. Ability to perform calculations of SVHC in products to help customers understand if they are under or over limit within their full product design.
11. Self-Driven to continuously learn about current and expanding regulations as well as new ones on the horizon to represent LEMO USA and Northwire’s position and respond accordingly to requests.
12. Supports  LEMO USA and Northwire’s technical declarations within customer and 3rd party compliance portals.
13. Work with LEMO subsidiaries as necessary to provide joint support on regulatory submissions.
14. Partner with QC Compliance Engineering Department to ensure the Material Selection Guide (MSG) stays up to date for design engineering use.
15. Maintains all regulatory records, process documentation, and ERP system information and updates.
16. Educate departments on new regulations and their effective dates.
17. Support engineering on design changes needed to meet and maintain compliance.
18. Support regulatory investigations and respective corrective/preventative actions.
19. Drive the Preferred Materials List for NPI and product design.
20. Represents NWI for verification & validation of regulatory compliance documentation and processes controls during audits.
21. Additional duties as assigned.
22. Coordinate LEMO USA and Northwire’s data integration and support for a global database (i.e., Teexema)

It is the responsibility of all Team Members to:

• Proactively ensure a safe working environment for Team member and guests
• Live and model the Vision, Mission, Quality policy and Safety Policies
• Create a culture of performance as evidenced by continual improvement in Safety, Quality, Innovation and attaining company sales revenue and earnings growth targets
• Create a learning organization that can adapt to changing market needs
• Abide by Code of Ethics for Professional Conduct, utilizing appropriate professional and respectful behavior in all situations and maintaining absolute confidentiality.
• Support the delivery of high-quality products and services that exceed customer expectations.

Competencies:

Candidate should be educated on the following directives, standards, and ISO QMS as a min:

• EU MDR Regulations & Reporting
• EU Waste Frame Directive (SCIP Database)
• REACH / RoHS / RoHS3 / China RoHS
• Proposition 65
• TSCA
• TSE/BSE Risk Analysis
• TBA/TCA/ISPM 15
• Dodd – Frank Act on Conflict Minerals (i.e., CMRT & CRT)
• ISO 9000 / ISO 13485 / AS9100
• Basic Understanding of Product Compliance (i.e., UL/CSA)

Candidate should have a high level of experience creating the following document types:

• IMDS (i.e., materials breakdown by construction level, substance ID, & amounts in the product) a plus
• Product SDS / TDS
• Compliance Declarations
• Dossiers

Candidate should exhibit the following skillsets:

• Subject matter expert on Regulatory Compliance topics
• Ability to lead meetings with and answer questions directly from supplier’s regulatory departments
• High level of organization with the ability to own and build the infrastructure for the regulatory data
• Materials knowledge (i.e., polymers/plastics, metals/metal alloys/metal coatings, polymer tapes, etc.)
• Experience with wire and cable, cable assemblies, connectors, or cable components a plus
• Excellent verbal and written communication skills, with ability to communicate to all levels
• Sense of Urgency for Customer Responses and Workload
• Attention to Fine Details
• Strong sense of Accountability
• English Proficiency Level: C1 (Advanced)

Supervisory Responsibility: 

This position has responsibilities for collaboration with LEMO USA / Northwire and LEMO Group Regulatory Compliance Team.

Work Environment:

This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. This position may require to be on the production floor with proper use of PPE.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this position, the TEAM Member is frequently required to talk or listen to fellow TEAM Members. The TEAM Member is frequently required to stand, walk, use full hand functions, and reach with hands and arms.

Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Expected Hours of Work:

The hours of work and days are Monday through Friday between 40-45 hours and may vary based on business needs.

Travel:

Travel may be expected for this position.

Relocation:

No relocation is expected for this position.

Required Education:

Min. Degree in Regulatory Compliance, Engineering, Polymers, or Regulatory Compliance Certificate with 3+ years of equivocal industry experience.

Required 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)
• Extensive time and project management skills to set and deliver on priorities and deadlines

Additional Eligibility Qualifications or Certifications:

• 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
• Experience with QAD and QCBD systems is an advantage
• Working with international subsidiaries for compliance to local country or regional regulations
• Multi-lingual is a plus (i.e., English – French, English – Spanish, English – Swiss French)

Work Authorization/Security Clearance (if applicable):

N/A

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the TEAM Member for this job. Duties, responsibilities, and activities may change at any time or without notice.

How to Apply: 

Apply on website or pick up an application on site.

Northwire, Inc. is an Equal Opportunity Employer – M/F/D/V