Sr. Regulatory Specialist

  •  

Boston, MA

Not Specified years

Posted 174 days ago

  by    Cynet EngineeringTeam

This job is no longer available.

??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)