Contract Opportunity: Regulatory Affairs Specialist in Franklin Lakes NJ —


I am Raj Charan, Sr. US IT Recruiter for Indotronix International Corporation. I just looked into your profile in Dice/Monster/Database and found your skills are exactly matching with our Direct Client Requisition. I am wondering if you are available for any new assignments so that we can process your resume towards the Hiring Manager at Client Location accordingly we can schedule a Client Call.

Req# – Regulatory Affairs Specialist

Work Location: Franklin Lakes NJ

Start Date: ASAP

End Date: 10/31/2012

Total # of positions: 1

Job Description:


Enter qualifications here Qualifications – External – B.S. degree in the biological sciences, chemistry or related science preferred – 2-5 years experience in the device/diagnostic, biologic and/or pharmaceutical industry, primarily in the area of regulatory affairs. – Current knowledge of U.S. medical device regulatory requirements, and Quality System Regulations (QSR); current knowledge of European Medical Device Directive, European quality system standards and other Global Markets – Demonstated ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization. – Proven ability to organize work; project management experience desirable.


Position is responsible for the preparation of regulatory submissions required to market new or modified medical devices in both the U.S., Europe and all global markets. Responsibilities: – Coordinate, prepare, and follow up with FDA Premarket Notification [510(k)] submissions in a timely manner. Act as liaison with FDA regarding product clearance – Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications" (U.S.) for changes that do not require a 510(k) submission – Submit product listing to the FDA when deemed necessary – Request FOI information and maintain FOI files – Prepare technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner – Submit notification to the Notified Body about significant changes to CE marked products in a timely manner – Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions – Track and monitor all assigned projects – Review/approve labeling, promotional and advertising materials to ensure regulatory compliance, as assigned – Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance – Represent RA in product life cycle development teams by reviewing, approving, and completing ACR (change management) requirements – Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis – Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers – Carry out the above tasks with minimal


Raj Charan

Indotronix International Corporation

331 Main Street, Poughkeepsie, NY 12601

(845) 625-2154 x 8052 845-473-1197

: Rajcharan.recruiter Raj

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IIC is a 25+ years old software solutions and consulting organization providing Contract Staff Augmentation to our direct clients including Accenture, AON, Becton, Tyco, Siemens, Atos, SAS, McKenzie, Verizon Wireline, Verizon Wireless, SAP America, Unisys, Capgemini, Frontier, Dean Foods to list a few. Please visit to know more about us.


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