Regulatory Specialist II - Scarborough Maine

Company: Spectraforce Technologies
Location: Scarborough, Maine
Posted On: 05/03/2024

Job Title: Regulatory Specialist II
Location: Scarborough, ME 04074
Duration: 7 Months

Duties:

• Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
  
• Provides regulatory support for diagnostic product development and commercial diagnostic products.
  
• Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
  
• Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
  
• Researches and communicates scientific and regulatory information in order to write submission documents.
  
• Compiles and publishes all material required for submissions, license renewals, and annual registrations.
  
• Maintains approvals/licenses/authorizations for existing marketing authorizations.
  
• Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
  
• Develops internal procedures and tools.
  
• Conducts informational or training sessions for stakeholders.
  
• Organizes and maintains hard copy and electronic department files.
  
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
  
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
  
  Skills:
  
  
  
  
  • Good knowledge of EU and international regulations.
    
  • Demonstrated written and verbal communication skills.
    
  • Strong time management skills, with the ability to work on multiple projects simultaneously.
    
  • Ability to work independently as well as within a team.
    
  • Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio
    
    Required Qualification:
    
    
    
    
    • Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
      
    • 4+ years' experience in Regulatory Affairs role.
      
    • Strong knowledge of IVDR and EU regulatory requirements is required.
      
      Preferred Qualification:
      
      
      
      
      • 1+ years' experience in an IVD or medical device manufacturing environment.
        More...

            

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