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Principal Regulatory Affairs Specialist

Regulatory & Quality Assurance
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  • Excellent writing skills with ability to write detailed information for submissions
  • Excellent ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations
  • Strong verbal skills including presentation skills
  • Strong interpersonal skills including the ability to interact with all levels of the company
  • Strong computer skills including Microsoft Office

Preferred Skills/ Qualifications

  • Excellent working knowledge of medical device regulations (21CFR) and FDA law
  • Solid working knowledge of the regulatory requirements related to European medical device directives
  • Capacity to communicate regulations to technical functions within the company
  • Ability to manage relationships with FDA
  • Experience with document control systems such as Agile and Oracle
  • Medical device software submission and validation experience highly desirable


  • Bachelor’s degree (BA or BS) from a four year college or university in an engineering or science discipline (preferred)


  • Minimum of 7+ years’ experience in an FDA regulated industry preparing regulatory submissions for medical devices

Additional Details  

  • There may be limited domestic travel

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.


Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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