• Regulatory Affairs Associate - exp

    Job Location(s) US-NJ-Allendale
    Posted Date 1 month ago(12/12/2018 7:09 AM)
    Job ID
    2018-30251
    Category
    Other
    Position Type
    Contract (Full-Time)
    # of Openings
    1
  • Overview

    This role will require a detail oriented individual capable of managing multiple tasks while keeping the big picture in mind. Up to 20% travel may be required.

    Responsibilities

    • Support Regulatory Affairs integration and product life cycle management activities. 
    • Responsible for evaluation, drafting and remediation of regulatory affairs documentation. 
    • Responsible for preparation of Regulatory Affairs submissions. 
    • Responsible for review and drafting of procedures to meet client's corporate standards and relevant regulatory requirements. 
    • Responsible for support of sustaining regulatory activities at both sites including regulatory evaluation of product changes, marketing collateral, labeling, etc. 
    • Reporting progress on key integration initiatives and projects to management. 

    Qualifications

    • Must be proficient in Microsoft office (Work, Excel, Outlook). 
    • Bachelor’s Degree in engineering or Healthcare related field preferred. 
    • 2+ Years of Regulatory, Quality or R&D experience in a regulated industry. 
    • M&A experience a plus 
    • Experience interacting with FDA, Notified Bodies or Other Health Authorities Preferred. 
    • Strong communication skills and experience in cross functional teams are necessary.

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