Senior Regulatory Affairs @ Saraca Solutions

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Senior Regulatory Affairs

Saraca Solutions
5 - 10 years
Noida, Gurugram
6 months ago
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Job Description

Planning, organizing and implementing strategies and activities required to procure regulatory approval for new and revised product lines under the guidance of more senior regulatory professionals. Ensuring compliance to all US, EU

Required Candidate profile

510(k) and CE Marking; IDE, PMA (original/revision/supplements) preparation a plus
Minimum 1-year experience in FDA regulated industry
Working knowledge of Medical Device Regulations (FDA and EU)

Job Classification

Industry: IT Services & Consulting
Functional Area / Department: Legal & Regulatory
Role Category: Corporate Affairs
Role: Head - Regulatory Affairs
Employement Type: Full time

Contact Details:

Company: Saraca Solutions
Location(s): Noida, Gurugram

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Keyskills: strategy implementation regulatory requirements product development regulatory affairs marketing support drug safety hrsd literature review pharmacovigilance job description recruitment case processing computer systems information systems

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Preferred City (* max. 2 w/comma)

Designation / Expected Role

Current / Recent Company (*)

Experience (*)

Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

Add social media [ + ]

Create password

I agree with website service terms and conditions

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Saraca Solutions

SARACA is a global IT and engineering R&D services company with Fortune 500 customers. 80% of our customers are based in the (USA) with a 95% recurring business. Major services in medical, aerospace, semiconductor, & automotive industries

Senior Regulatory Affairs @ Saraca Solutions

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