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Regulatory Associate::gurgaon::immediate Joiner
Full time
Gurgaon
Not Disclosed by Recruiter
JOB DESCRIPTION:
Job Description::


Key Duties and Responsibilities



Directly involved in the preparation, assembly and submission of all global regulatory documents, such as 510(k), CE Mark Technical Files and other international regulatory submissions for various countries.

Responsible for performing duties in compliance with FDA, CMDR, Medical Device Directive 93/42/EEC (and all applicable amendments); and other international regulatory requirements.

Interact with representatives of domestic and international partners, subsidiaries and international regulatory authorities to discuss regulatory issues and submission requirements.

Acts as liaison for company with regulatory agencies, as well as with other internal functional departments for new product submission strategy.

Read, review, interpret and keep current with regulations and publications regarding device and drug products with primary focus on medical devices and combination products.

The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide including EU.

Assess the acceptability of quality, preclinical and clinical documentation for submission filing Compile, prepare, review and submit regulatory submission to authorities



Essential Requirements



Bachelors/ Masters degree with minimum 3-5 years in Regulatory Experience

Excellent oral and written communication skills

Knowledge of FDA, European, Canadian and Japanese Regulatory Requirements

Proficiency in the use of technology including MS Office programs, electronic document repositories, electronic submission pathways and Internet resources required

Location::Gurgaon

Exp: 4+ Yrs

Notice period: Max 10 days.

Contract to hire.

Interested candidate please contact on below details.

Jagan Parida
Mob:8888833070
jagan@iquest-consultants.com
KEY INFORMATION:
Salary: Not Disclosed by Recruiter
Industry: IT-Software / Software Services
Functional area: IT Software - Application Programming ,
Role:Software Developer
Role category:Programming & Design
Key skills: Regulatory Associate Regulatory Specialist regulatory documents
DESIRED CANDIDATE:
Any graudate:Any Graduate - Any Specialization
Post graduate:Any Postgraduate - Any Specialization
Doctrate:Doctorate Not Required
Please refer to the Job description above
RECRUITER DESCRIPTION:
iQuest Management Consultants Pvt Ltd
iQuest Consultants are the biggest IT, Telecom, Manufacturing and Engineering and BFSI recruiters in West India, started in 2000, working for clients like Deloitte, IBM, KPMG, E&Y, Goldman Sachs, RBS, Standard Chartered, Tech Mahindra, Cable & Wireless, Samsung, Nokia etc. We work aggressively at Middle, Senior and Top Management levels for the Manufacturing and Engineering Companies like L&T, Hindalco, Finolex, Thermax, M&M, John Deere, Mercedes Benz and many more. Our overseas division works actively for some of the very reputed names in the Gulf like Al Moosa, Al Aqili, BEC, Technip, Al Abbas, ETA, Al Basti, ArchGroup, etc. Our priority is to deliver services that are highly competent, outstanding in quality and exceptionally professional.

ABC's roots in management consulting enable us to bring a unique approach to recruitment. Our focus has always been on middle and senior management talent needs. We recruit across various industry segments for multinational corporations as well as leading Indian business houses and in the past 45 years, we have helped shape the careers of over 145,000 professionals.
iQuest Management Consultants Pvt Ltd
iQuest Consultants are the biggest IT, Telecom, Manufacturing and Engineering and BFSI recruiters in West India, started in 2000, working for clients like Deloitte, IBM, KPMG, E&Y, Goldman Sachs, RBS, Standard Chartered, Tech Mahindra, Cable & Wireless, Samsung, Nokia etc. We work aggressively at...