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Regulatory affairs Specialist @ Saraca Solutions

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 Regulatory affairs Specialist

Job Description

Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements.
Excellent written, organizational, and communication skills is required, and have a flexible

Required Candidate profile

RA role in medical device,US FDA,EU
Bachelor degree in Medical,Mechanical,Electric Life Science/other healthcare related majors
8yrs exp for RA role in medical device/pharmaceutical industry

Job Classification

Industry: Engineering & Construction
Functional Area / Department: Legal & Regulatory
Role Category: Corporate Affairs
Role: Regulatory Affairs Compliance
Employement Type: Full time

Contact Details:

Company: Saraca Solutions
Location(s): Hyderabad

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Keyskills:   pharmaceutical usfda regulatory ra regulatory affairs ectd fda drug safety anda documentation ent pharmacovigilance regulatory requirements ich ctd clinical research quality assurance qms regulations drug regulatory affairs clinical trials

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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