Regulatory Affairs Specialist II

Company: Katalyst Healthcares & Life Sciences
Location: Denton
Posted on: May 28, 2023

Job Description:

Responsibilities:

• 
  
• Prepare regulatory documentation packages for review and submission to regulatory agencies or to our commercial partners to achieve departmental and organizational objectives.
  
• Prepare, submit and archive 510(k)s, Letters to File, EUMDR Tech Documents, Change Notifications. Respond to FDA and NB to address submission queries.
  
• Provide regulatory support to post-launch business maintenance activities under the guidance of Sr. RA personnel.
  
• Review labeling and engineering changes for compliance with regulatory filings
  
• Maintain current knowledge of FDA, ICH, and international guidelines.
  
• Responsible for other duties and projects as assigned.
  
  Requirements:
  
  
  • 
    
  • 2-5 years of regulatory affairs experience.
    
  • Experience with 510(k)s and EU MDR applications, supplements, change notifications, and approvals.
    
  • Strong organizational and follow-up skills, as well as attention to detail.
    
  • General understanding of global and U.S. regulatory processes.
    
  • Excellent project management skills with the ability to multi-task.
    
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
    
  • Excellent presentation skills, both written and in platform presentation format.
    

Keywords: Katalyst Healthcares & Life Sciences, Denton , Regulatory Affairs Specialist II, Other , Denton, Texas