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Staff Regulatory Affairs Specialist

Apply Now Job ID R-324595 Date posted 11/29/2018

Job Description Summary

This position is responsible for the preparation of regulatory submissions required to market new or modified medical devices in both the U.S. and Europe, and related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.

Job Description

  • 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.
  • 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.
  • Support International Regulatory Associates as it pertains to registering our devices worldwide.
  • Review/approve label/labeling, promotional and advertising materials to ensure regulatory compliance.
  • 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 requirements.
  • Submit product listing to the FDA when deemed necessary.
  • Request FOI information and maintain FOI files.
  • 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 no supervision.


  • B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry.
  • 5 years Regulatory Affairs experience in medical device and in vitro diagnostic device companies or 3 years of experience plus a Master's degree.


  • Prior experience with hazardous materials management preferred.
  • Demonstrated success in taking products through FDA, preferably CDRH.
  • International product registration experience preferred.
  • Proficient in using Microsoft Word, Excel and PowerPoint.
  • Strong communication and project management skills.
  • Must be able to handle multiple tasks and attention to detail.
  • Working knowledge of 510(k) (for both medical devices), MDD 93/42/EEC and working knowledge of 21 CFR 820 -Quality System Regulation, and working knowledge of standards and FDA guidance’s.
  • Working knowledge of all material related regulatory requirements (e.g., Prop 65, CONEG, DOT, IATA, IMO, OSHA, etc.) in the US, Europe and Canada.


Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

USA MA - Andover

Work Shift

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