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Regulatory Affairs Specialist 2

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Regulatory & Quality Assurance
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866 Total Views
Thanks for your interest in the Regulatory Affairs Specialist 2 position. Unfortunately this position has been closed but you can search our 248 open jobs by clicking here.
Qualifications:
  • Technical knowledge including (but not limited to) Biomedical/Life Sciences/Engineering/Clinical.
  • Understanding of medical device and IVD regulations in US and international markets.
  • Understanding of product life cycle process, design control and/or risk management.
  • Experience using Microsoft Office.
  • Effective technical writing and verbal communication skills.
  • Ability to work as part of a cross-functional team.
  • Ability to work in a fast paced environment with shifting changes in prioritization based on regulatory and business needs.
  • Ability to identify, understand, evaluate, and recommend solutions for complex regulatory problems.
  • Ability to work effectively with teams with limited supervision.
  •  Ability to learn in a fast-paced environment.
  • Ability to make and keep time bound commitments for project completion.
  • Project management skills preferred
  • Understanding of FDA, CE and ROW medical device and IVD regulations. Working knowledge of the medical device product lifecycle. Product design and manufacturing change assessments for regulatory reporting. International regulations and submissions.
Education          
  • Bachelors with 3 years of experience or Masters with 1 year of industry experience or equivalent.
  • Demonstrated success with regulatory submissions [510(k), PMA, Annual reporting, PMA supplements, 30 day notice, etc.] or equivalent.
 
Experience         
  •  Bachelors with 3 years of experience or Masters with 1 year of industry experience or equivalent
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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