Regulatory Affairs Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Jersey City
Posted on: January 21, 2023

Job Description:

Responsibilities

• 
  
• Provide guidance in preparing country specific dossiers for submissions worldwide.
  
• Generate templates for domestic (US FDA, Canada) and international (EU, Australia, Turkey, etc) submissions.
  
• Communicate directly with the international affiliates and the regulatory intelligence team.
  
• Update and maintain the submission templates.
  
• Liaison the requirements with the Product Manager and the development team.
  
• Manage the internal regulatory intelligence team.
  
• Create internal processes and systems to ensure regulatory intelligence provided by RegDesk is of the highest quality.
  
• Review work of regulatory intelligence team.
  
• Contribute ideas to enhance RegDesk's RIM platform.
  
  Requirements:
  
  
  • 
    
  • Bachelor's Degree or equivalent experience preferred
    
  • Minimum 5 years' experience in the Medical Device Regulatory Affairs
    
  • Thorough understanding of US, EU, Canada regulations on medical devices and IVDs
    
  • Prior experience authoring dossier content and addressing health agency inquiries is a must
    
  • Superior attention to detail
    
  • Strong written and verbal communication skills
    
  • Able to multitask effectively and work independently with international oversight
    
  • Knowledge of 21 CFR Part 11 requirements
    
    

Keywords: Katalyst Healthcares & Life Sciences, Jersey City , Regulatory Affairs Specialist, Other , Jersey City, New Jersey