Sr. Regulatory Specialist

Confidential Company  •  Boston, MA

Salary depends on experience
Posted on 05/25/18 by Cynet EngineeringTeam
Confidential Company
Boston, MA
Salary depends on experience
Posted on 05/25/18 Cynet EngineeringTeam

??We are looking for Sr. Regulatory Specialist for our client in Boston, MA

Job Title: Sr. Regulatory Specialist

Job Location: Boston, MA

Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire

Job Description:

Duties:

 

  • Should have majority experience in Medical Devices or In-vitro diagnostic devices
  • Should be aware of Regulations (MDD) for Medical device profiles
  • Shoud be aware of regulations (IVDD) for IVD profiles

 

Educational Qualification such as below will be ideal:

 

  • Master of Science in Regulatory Affairs in Drugs, Biologics and Medical Devices
  • Masters in Biochemistry for IVD requirements

 

Key search words:

 

  • Knowledge on Part 820, Part 11, ISO 13485, MDD/IVDD, IEC 60601x, IEC 62304, ISO 14971, GxP, GHTF Guidelines
  • ISO 13485/900 Lead Auditor, RAPS certification would be an added advantages
  • Working experience with different Notified Bodies for CE Marking
  • EU MDR (2017/745)
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