Product Regulatory Affairs Engineer I
About The Position
As a Product Regulatory Affairs Engineer, you will be responsible to investigate, coordinate, and execute defect reporting as required by government agencies. This role also requires monitoring and investigating new complaints of possible emissions defects arising from warranty claim threshold exceedances, quality data, or internal data suggesting a possible defect. The person in this role will follow up on defect investigations by tracking and documenting the progress of the investigation and providing management with decision material for the topic. Regular updates are to be given in technical reviews regarding any potential defect reports. The Product Regulatory Affairs Engineer will also compile required documentation for submission to government agencies if ever a defect report is required. This role requires work in a cross functional team setting including Engineering, Quality, Warranty, Service, and regulatory agencies. Additionally, this role will support Product Integrity in evaluating new and existing emissions relevant Aftermarket Parts. Support includes providing regulatory guidance, defining and reviewing testing requirements, and documenting part release decisions. The Product Regulatory Affairs Engineer will ensure evaluations are managed cross-functionally, compliance evaluation processes are followed, and documentation is created and stored. This role requires work in a cross functional environment with Aftermarket, Product Engineering, Product Integrity, and Legal teams.
Requirements
- Bachelor of Science Degree in Engineering or related discipline from an ABET accredited university and 0-2 years relevant industry experience, is required.
- Familiarity with root cause analysis
- Knowledge of Problem solving methodologies
- Experience with predictive modeling/statistics/trend analysis
- Experience working in a project team and collaborating with others
- Ability to execute independently
- Strong oral and written communication skills.
- Strong organizational skills.
- Strong interpersonal skills and ability to collaborate with others.
- Strong PC skills including MS Office and database tools.
- An attached resume is required.
Nice To Haves
- 2+ years relevant industry experience
- Background in Emissions Compliance/Regulatory Affairs
- Technical background regarding component design and validation
- Technical background regarding engineering drawing interpretation
- Advanced degree (Master’s or higher) in Engineering or related discipline
Responsibilities
- Compile and distribute required defect reporting to regulatory agencies for emission related vehicle components
- Analyze warranty data for relevant components trending upward toward or above the regulatory reporting thresholds
- Utilize predictive modeling to identify and define where components maybe affecting emissions warranty and reporting obligations
- Work cross functionally to investigate, monitor, document, and report any discovered emission related defects
- Draft recall and campaign notification together with Quality and Service department and publish to the regulatory agencies
- Ensures defect reports and recall documents are in compliance with external regulations and internal standards
- Ensure data is complete and accurate per the regulatory requirements
- Interprets and evaluates proposed regulations and advises management on impact to the organization regarding Warranty and Aftermarket Parts requirements
- Implements and audits processes to ensure compliance with applicable regulations and internal standards
- Evaluate Aftermarket parts relevance for emissions together with responsible component engineers
- Provide advice to development and/or marketing teams on product changes, quality testing requirements, product labelling, literature, and advertising
- Document and track Aftermarket parts decisions regarding development and validation
- Prepare and submit certification documentation as needed for Aftermarket parts
Benefits
- annual bonus program
- 401k company contribution with company match up to 6% as well as non-elective company contribution of 3 - 7% depending on age
- starting at 4 weeks paid vacation
- 13+ calendar holidays
- 8 weeks paid parental leave
- employee assistance program
- comprehensive healthcare plans and wellness programs
- onsite fitness (at some locations)
- tuition assistance and volunteer paid time off
- short-term and long-term disability plans
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
