Regulatory Compliance Engineer

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Regulatory Compliance Engineer

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    Regulatory Compliance Engineer
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Regulatory Compliance Engineer

We are looking for a Regulatory Compliance Engineer for a 6 month contract working to ensure our advanced cancer treatment devices are able to enter into new markets.

The Regulatory Compliance Engineer will work closely with R&D team throughout the product design, installation, and service lifecycle to identify product safety and compliance requirements, support engineering and product management understanding of requirements, ensure adequate assessment and demonstration of compliance during design control.


  • Identification of product standards that apply to our product line and operations.
  • Develop and maintain standards and technical competency to effectively communicate and support organization understanding of product standard requirements.
  • Provide direction/guidance on how to comply with the applicable design/safety standards and ensure compliance is achieved
  • Assess and ensure compliant product design.
  • Establish requirements/design for labeling of the product per design/safety standards
  • Prepare and/or support the development of Verification and Validation plans, protocols, and test records to ensure and evidence compliance.
  • Complete traceability of applicable standard requirements, compliant product design, and verification and validation of satisfaction.
  • Responsible for coordinating or performing verification testing and generating test reports to satisfy product requirements derived from applicable safety and regulatory standards, such as electrical and EMC testing.
  • Review product design changes with the responsibility for determining if changes are relevant to applicable safety and regulatory compliance as well as coordinating and performing regression testing if necessary.


  • Bachelor’s Degree in electrical/mechanical engineering, industrial engineering or relevant experience with 5-10 years in a similar position responsible for design/safety systems compliance.
  • Experience and understanding of federal and international design/safety standards requirements.
  • Hands-on testing experience for EMC/EMI and performance/safety compliance to test the safety and compliance of the designs during product design and development.
  • Excellent writing and communication skills (will work with internal design engineering team) are critical for the generation and review of Design History File documentation
  • Experience with medical device development under FDA Quality Systems Regulations, Medical Device Directive (MDD) and/or Medical Device Regulations (MDR), and Rest-of-World regulatory schemes.  


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