Regulatory Affairs Associate

Company: TalentBurst, Inc.
Location: Saint Paul
Posted on: March 19, 2023

Job Description:

Title: -Regulatory Affairs Associate
Location: -St. Paul, MN
Duration: 9+ Months

Job Description

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• The Electrophysiology (EP) Regulatory Affair Associate will work from our St Paul location support the regulatory department to ensure efficient and compliant business processes and environment. -
  
• In this role, you may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. -
  
• You will participate in preparing and submitting documentation needed for registration worldwide, with a focus on Latin America.
  
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  Key Responsibilities
  
  
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  • Ensure ****** products and procedures comply with applicable regulatory agency requirements and guidelines.
    
  • Responsible for review Product Release activities in Windchill including maintaining accurate master data and support any other assigned projects such as data clean up.
    
  • Support GMP certificate and in country certificates activities.
    
  • Work with cross-functional teams to support regulatory submission, change management and product release activities.
    
  • Manages concurrent deadlines and meets deadlines for assigned work/tasks.
    
  • Comply with company initiatives in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), FDA & world-wide regulations, business requirements, company policies and operating procedures.
    
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    Qualifications
    
    
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    • BA or BS degree in health science, regulatory, business, engineering or equivalent combination of education and work experience.
      
    • Ability to manage projects and drive them to completion with attention to detail.
      
    • Requires ability to be innovative, resourceful, and work with minimal direction.
      
    • Strong written and verbal communication, at all organizational levels.
      
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
      
    • Experience working in medical device industry with focuses on regulatory, or quality systems preferred.
      
    • Strong problem-solving skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
      
    • Skilled in Microsoft Office specifically Excel, PowerPoint, and Word.
      
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      Preferred
      
      
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      • Fluency in Spanish and/or Portuguese desired, but not required.
        
      • Experience in regulatory affairs preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area, especially if it is in the medical device industry.
        

Keywords: TalentBurst, Inc., St. Paul , Regulatory Affairs Associate, Other , Saint Paul, Minnesota