Senior Regulatory Affairs Specialist – Medical Device & Software

Senior Regulatory Affairs Associate – Medical Device & Software
Greater Chicago Area, IL

Job Requisition:  6340
 
Description for Senior Regulatory Affairs Associate – Medical Device & Software:
The Senior Regulatory Affairs Associate provides regulatory support and expertise within both global and US medical device products.  Will create global regulatory strategies and ensure regulatory compliance of all documents for submissions and change management. 
 
Responsibilities for Regulatory Affairs Associate – Medical Device & Software:
  • Provides regulatory advice and support medical device products containing embedded software
  • Identify registration needs and create regulatory strategies
  • Plan and organize regulatory documentation for medical device products 
  • Focus on medical device products that contain embedded software 
  • Prepare regulatory submissions (510(k), (EU technical files) adhering to local regulatory requirements and guidelines
  • Serve as liaison with regulatory agencies on a specific medical device product line
  • Help to prepare documentation and strategies for regulatory agency meetings
  • Review and approve critical regulatory documentation and technical reports
  • Identify registration documentation deficiencies and work with team to resolve
  • Evaluate manufacturing and labeling changes for regulatory impact with guidance  
  • Represent Global Regulatory Affairs team at Company meetings and/or serve as regulatory lead for a medical product team
  • Maintain awareness of applicable regulations
Requirements for Regulatory Affairs Associate – Medical Device & Software:
  • Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related scientific degree 
  • 3+ years regulatory affairs experience within medical device industry
  • Experience authoring or contributing to 510K regulatory submission required. 
  • Experience working cross functionally with software engineers on regulatory standards
  • Experience with Medical Device Reporting (MDR)  
  • RAC Certification Preferred 
  • Strong oral and written skills 
 

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