Regulatory Specialist

Pleasanton, CA Pleasanton CA 94588

Date : Jul-24-18

Regulatory Specialist

Pleasanton, CA

Jul-24-18

Work Authorization

US Citizen
GC
H1B
GC EAD

Preferred Employment

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

Job Details

Experience

:

Senior

Rate/Salary ($)

:

Market

Duration

:

Long Term

Sp. Area

:

Others

Sp. Skills

:

Others

Consulting / Contract

H1B OK

Third Party OK

Direct Client Requirement

Required Skills :

regulatory PMA (Pre-market Approval), submission writing, ME, QE supply chain and RA management, R&D

Preferred Skills :

Domain :

HealthCare, Pharmaceuticals

Work Authorization

US Citizen
GC
GC EAD
H1B

Preferred Employment

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

Job Details

Experience

:

Senior

Rate/Salary ($)

:

Market

Duration

:

Long Term

Sp. Area

:

Others

Sp. Skills

:

Others

Consulting / Contract

H1B OK

Third Party OK

Direct Client Requirement

Required Skills :

regulatory PMA (Pre-market Approval), submission writing, ME, QE supply chain and RA management, R&D

Preferred Skills :

Domain : HealthCare, Pharmaceuticals

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Vinsys Information Technology Inc
Reston, VA
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Job Description :

Title: Regulatory Specialist

Location: Pleasanton, CA

Duration: Contract

Job Description:

Responsible for providing a global regulatory assessment to determine impact of supplier transfer activities
Experience in medical devices which has mechanical & electrical components
Experience in various type of regulatory submissions, especially PMA (Pre-market Approval)
Experience in submission writing
Responsible to work with internal SME team (R&D, ME, QE, supply chain and RA management) to identify the deliverables needed for regulatory submission.
Reviewing design/V&V/risk assessment/validation activities to ensure it meets global regulatory requirements.
Follow relevant procedures to ensure compliance
Play the role of primary Regulatory point person

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