Sr. Regulatory Compliance Engineer
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 for the organization. Responds to inquiries from regulatory agencies and completes required compliance documentation. Ensures operating manuals and procedural documents stay current when regulations change.
- Creates and establishes a robust process within our ERP systems 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.
- Identify industry/enterprise trends and emerging risks to enhance the risk and control plan.
- Develop and maintain accurate compliance reports.
- 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 in order to represent Northwire’s position and respond accordingly to requests.
- Ownership of Northwire’s technical declarations within customer and 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.
- Collaborate with design engineers in the early stages of product development to ensure compliance ready designs as necessary.
- Support engineering on design changes needed to meet and maintain compliance.
- Support regulatory investigations and respective corrective/preventative actions.
- Represents NWI for verification & validation of regulatory compliance documentation and processes controls during audits.
- All other duties as assigned
Min. Degree in Regulatory Compliance, Engineering, or Regulatory Compliance Certificate with 10+ years of equivocal industry experience.
- Direct experience with Regulatory Compliance Risk Management.
- Intermediate level of experience with Microsoft Excel to use functionality in analyze big data.
- 4+ years of regulatory compliance experience from any industry (i.e. manufacturing, medical device, automotive, aerospace, industrial)
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.
- Excellent verbal and written communication skills, with ability to communicate to all levels of the organization.
- Multi-lingual is a plus (i.e. English – French)
Northwire, Inc. is an Equal Opportunity Employer – M/F/D/V