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Intern, Regulatory Affairs

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Regulatory & Quality Assurance
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The Summer Internship Experience: Make a Difference

As a Hologic Intern, you are not just taking a summer job; you are taking your place on a global team of motivated, creative and amazing people!  The summer internship experience gives you the opportunity to shine and share your knowledge, energy, and passion on meaningful projects that impact people all over the world. In addition to a project that will provide maximum experience and exposure in your desired field the Hologic College Relations team provides opportunities to learn more about the company, network with leadership, and develop the skills needed to succeed in a global organization.

 

Only active students will be considered for internships & co-ops at Hologic.  Candidates who have completed their most recent degree program will not be considered for this internship. 


The Diagnostics RA team is charged with supporting rapid, global commercialization of Hologic Diagnostics Division products by implementing effective regulatory strategies, coordinating submission of high-quality applications, negotiating successful marketing approvals and maintaining compliant products for customers world-wide.

In this project the student selected will:
  • Coordinate team staff meetings including  
  • Maintain/improve RA department sharepoint site 
  • Partner to establish a RA team Visual Metrics Board in the RA area  
  • Completion of Regulatory Information Review (RIR) assignments for new or revised regulations/guidance
  • Training/execution of submissions content QC and Publishing, including paper and eCopy submissions.  Under the supervision of RA staff, learn and effectively contribute to NPD and International submissions
  • Assist with FDA Pre-Sub meeting note-taking, preparation and submission of draft meeting minutes if scheduled during the Internship. 
  • Under the supervision of RA staff, contribute to development of IVDR compliant Tech File structure.   
  • Training/execution on international registrations for new and legacy products. Under the supervision of RA staff, work directly on assigned international submissions.
  • Learn international submission intake process
  • Learn proper entry of regulatory information into corporate databases (RRS) and harmonized submission templates (STED, etc.)  
  • Learn how to work with affiliates and distributors to provide regulatory deliverables according to established timelines 
  • Learn how to obtain regulatory certificates CFS/COE/CFG  
  • Learn process for document legalization/authentication, including notarization, apostille, embassy/department of state legalization  


In order to be considered for this internship you must:

  • Actively enrolled as a rising senior or 1st year graduate student
  • Majoring in: Regulatory Science, Molecular Biology, Biomedical Sciences, Engineering (Biomedical, Software, Mechanical)
  • Have a 3.2/4.0 GPA
  • Strong written and verbal communication skills
  • Proficiency in Microsoft Office
  • Basic statistics
  • Knowledge of regulatory affairs fundamentals
 
 

Hologic, Inc. is proud to be an Equal Opportunity Employer & VEVRAA Federal Contractor


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