Senior Regulatory Affairs

Saraca Solutions

5 - 10 years

6 - 10 Lacs

Gurugram Bengaluru

Posted:2 days ago| Platform:

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Skills Required

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

Work Mode

Work from Office

Job Type

Full Time

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 plusMinimum 1-year experience in FDA regulated industryWorking knowledge of Medical Device Regulations (FDA and EU)

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Saraca Solutions

Information Technology and Services

Bangalore

200 Employees

107 Jobs

Key People

John Doe

CEO
Jane Smith

CTO
Richard Roe

VP of Sales

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Senior Regulatory Affairs