Re:Build Manufacturing
Regulatory Compliance Engineer
Kalamazoo, MImidAdded 1 month ago
About this role
This Regulatory Compliance Engineer role supports new product development (NPD) projects within a dynamic manufacturing environment. You'll ensure product safety and compliance by leading risk management, developing verification processes, and supporting various engineering functions. The ideal candidate thrives in a fast-paced setting and possesses a strong understanding of regulatory requirements.
What you'll do
- Lead risk management activities and coordinate reviews.
- Support creation of Design History Files and ensure compliance.
- Develop project plans to optimize quality, schedule, and cost.
- Conduct research to establish product requirements.
- Support production engineers with process analysis and qualification.
- Oversee design for basic safety requirements.
What they're looking for
- Regulatory Compliance
- Risk Management
- Statistical Analysis
- Problem Solving
- Communication
- Project Management
- Quality Management Systems
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Re:Build Manufacturing
- Industry
- Manufacturing
Likely interview questions
- Describe your experience with risk management processes, specifically within a regulated industry.
- How familiar are you with Design History Files (DHFs) and ensuring compliance with Quality Management Systems?