Regulatory SpecialistBoston, MA

Boston, MA Boston MA 02298

Date : May-10-18

Regulatory SpecialistBoston, MA

Boston, MA

May-10-18

Work Authorization

US Citizen
GC
H1B
EAD (OPT/CPT/GC/H4)

Preferred Employment

Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire

Job Details

Experience

:

Architect, Senior, Midlevel

Rate/Salary ($)

:

open

Duration

:

Sp. Area

:

Engineering

Sp. Skills

:

Mechanical

Permanent Direct Hire

Direct Client Requirement

Required Skills :

Regulations (MDD), DHF, 510k, Part 820, MDD/IVDD, IEC 60601x, GxP, GHTF, CE Marking, Medical Devices or In-vitro diagnostic devices

Preferred Skills :

Regulations (MDD), DHF, 510k, Part 820, MDD/IVDD, IEC 60601x, GxP, GHTF, CE Marking, Medical Devices or In-vitro diagnostic devices

Domain :

IT/Software, Financial, Government, HealthCare, Retail, Dot Com, Insurance, Pharmaceuticals, Manufacturing, Telecom

Work Authorization

US Citizen
GC
EAD (OPT/CPT/GC/H4)
H1B

Preferred Employment

Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire

Job Details

Experience

:

Architect, Senior, Midlevel

Rate/Salary ($)

:

open

Duration

:

Sp. Area

:

Engineering

Sp. Skills

:

Mechanical

Permanent Direct Hire

Direct Client Requirement

Required Skills :

Regulations (MDD), DHF, 510k, Part 820, MDD/IVDD, IEC 60601x, GxP, GHTF, CE Marking, Medical Devices or In-vitro diagnostic devices

Preferred Skills :

Regulations (MDD), DHF, 510k, Part 820, MDD/IVDD, IEC 60601x, GxP, GHTF, CE Marking, Medical Devices or In-vitro diagnostic devices

Domain : IT/Software, Financial, Government, HealthCare, Retail, Dot Com, Insurance, Pharmaceuticals, Manufacturing, Telecom

Apply Now

saxon global
Dallas, TX
Post Resume to
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Job Description :

Hi,
Hope you are doing well.
I have an urgent position with one of my direct client which are given below.
If you find yourself suitable for this position, please send me a copy of your latest updated resume along with the contact details.
Feel free to reach me at or) to discuss more about this opportunity.

Position : Regulatory Specialist
Location : Boston, MA
Duration : Long Term Contract

Job Description:
Should have majority experience in Medical Devices or In-vitro diagnostic devices
Should be aware of Regulations (MDD)
Extensive Experience in compiling DHF & doing 510k submissions
Extensive Experience in regulatory activities related to electro mechanical - medical devices
Experience in Change management
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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