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Senior Regulatory Affairs Specialist

Regulatory & Quality Assurance
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Thanks for your interest in the Senior Regulatory Affairs Specialist position. Unfortunately this position has been closed but you can search our 186 open jobs by clicking here.


  • 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; additional experience with international registration requirements highly desirable
  • Capacity to communicate regulations to technical functions within the company
  • Ability to manage relationships with FDA and international customers (e.g., regulatory agencies, distributors, etc.)
  • Experience with document control systems such as Agile and Oracle
  • Medical device software submission and validation experience highly desirable
  • Certified regulatory affairs professional highly desirable


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


  • Minimum of 5+ years’ experience in an FDA regulated industry preparing regulatory submissions for medical devices

Additional Details  

  • There may be limited domestic or international 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 & VEVRAA Federal Contractor

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