What are the responsibilities and job description for the Regulatory Compliance Specialist position at Northwire, Inc.?
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 :
- Creates and establishes a robust infrastructure within our ERP system to track, monitor, and alert the proper teams of Regulatory Compliance Changes / Updates.
- Establish risk mitigation planning process and standardized communication policy within 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 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 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 LEMO USA and Northwire’s position and respond accordingly to requests.
- Supports LEMO USA and Northwire’s technical declarations within customer and 3rd party compliance portals.
- Work with LEMO 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.
- Educate departments on new regulations and their effective dates.
- Support engineering on design changes needed to meet and maintain compliance.
- Support regulatory investigations and respective corrective / preventative actions.
- Drive the Preferred Materials List for NPI and product design.
- Represents NWI for verification & validation of regulatory compliance documentation and processes controls during audits.
- Additional duties as assigned.
- 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 :
Competencies :
Candidate should be educated on the following directives, standards, and ISO QMS as a min :
Candidate should have a high level of experience creating the following document types :
Candidate should exhibit the following skillsets :
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.
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 :
Additional Eligibility Qualifications or Certifications :
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.
