BrightOwl Loader Loading

Regulatory Compliance Engineer - United States  

Company managed [?] Still accepting applications

Posted on : 13 June 2017

Project Description

BASIC SUMMARY:
  • Key Role for the development and execution of product regulatory compliance programs within Microbial Solutions.  
  • Ensures product compliance by researching and identifying applicable regulatory and industry compliance standards and codes. 
  • Develops compliance polices and strategies.



ESSENTIAL DUTIES AND RESPONSIBILITIES:
  •   Provide input to create and implement regulatory compliance plans for product development programs
  •   Identifies compliance related risks, effectively communicates and develops approaches to avoid or reduce the risk
  •   Provide regulatory interpretation support and guidance to design and test engineers
  •   Participates with compliance plan reviews and safety design review meetings for products, early in the design cycle
  •   Facilitate product and system testing internally and externally to ensure regulatory compliance in the target markets, while creating and focusing on quality, cost and schedule goals
  •   Perform all other related duties as assigned


Qualifications
  • Education: Bachelor’s degree in Engineering, Manufacturing Engineering, Biomedical, Science, Physics or other technical discipline. Equivalent work experience will also be considered
  • Experience: 3+ years’ experience on regulatory complianc3e, on both software and hardware based products.
  •   Must possess experience in providing direction and taking the lead on regulatory input during the product design process.
  •   Exposure to ESD, EMC, EMI and product safety testing and country certifications or homologations
  •   Understands manufacturing and supply chain issues as they relate to phase-in of compliance-driven design changes
  •   Ability to explain and document regulatory and standards requirements
  •   Demonstrated strong and effective verbal, written, and interpersonal communication skills, enabling effective technical discussions with design and test engineers, labs and EU authority engineers.
  •   Previous experience with FDA and/or CDRH approvals and reporting as well as efforts on EMC and/or Product Safety certifications is highly preferred .
  •   An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Certification/Licensure: None .



Equal Employment Opportunity
Our company is an Equal Opportunity Employer M/F/Disabled/Vet