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Senior Regulatory Affairs Specialist

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Regulatory & Quality Assurance
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2547 Total Views
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.

Qualifications  

  • 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

Education  

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

Experience  

  • 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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