Regulatory Affairs Specialist

Join our clients mission to bring quality diagnostics to labs around the world.

As a Regulatory Affairs Specialist, you'll play a vital role in supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition-ensuring company's CE-marked products continue to meet the highest global standards of safety, quality, and compliance. This is an exciting opportunity for someone who enjoys working at the intersection of science, regulation, and innovation, and who takes pride in building the documentation and structure that make regulatory excellence possible.

• 
  

  Support the IVDR transition for all CE-marked products by preparing and revising technical files to the latest standards.

  
  
• 
  

  Generate comprehensive technical files that clearly present product characteristics, performance data, and evidence of conformity using the most recent templates and documentation requirements.

  
  
• 
  

  Collaborate cross-functionally with Quality, R&D, Manufacturing, and Regulatory teams to ensure all documentation is accurate, complete, and delivered within defined timelines.

  
  
• 
  

  Participate in weekly project meetings to address technical questions, track progress, and maintain alignment with project managers.

  
  
• 
  

  Support labeling conversion projects, updating specifications, conversion logs, and ensuring compliance with IVDR requirements.

  
  
• 
  

  Assist in un-CE marking activities, ensuring product labeling reflects updated regulatory status and is aligned with specification documents.

  
  
• 
  

  Update tracking logs, coordinate regional notifications, and communicate with the RA SAP restriction coordinator to manage product distribution restrictions where necessary.

  
  

• 
  

  Bachelor's degree in Biochemistry, Biology, Medical Technology, or a related scientific field.

  
  
• 
  

  3-5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD or medical device industry.

  
  
• 
  

  Solid understanding of FDA and CE-marking requirements for IVD products (IVDR knowledge strongly preferred).

  
  
• 
  

  Excellent communication, analytical, and problem-solving skills, with the ability to work both independently and collaboratively.

  
  
• 
  

  Strong attention to detail, organization, and ability to manage multiple tasks within set deadlines.

  
  
• 
  

  Proficiency with Microsoft Office, document control systems, and regulatory databases.

  
  

After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play.

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.