Analogic

  • Regulatory Affairs Manager

    Job Locations US-MA-Peabody
    Posted Date 1 month ago(5/21/2019 4:10 PM)
    Job ID
    2019-1739
    # of Openings
    1
    Category
    Regulatory and Compliance
    Type
    Regular Full-Time
  • Overview

    BK Medical is a leading provider of ultrasound-based, intraoperative guidance for surgical procedures within the U.S. and international healthcare markets. Reporting to the Sr. Director of Regulatory & QA, the Regulatory Affairs Manager will be responsible for overseeing the regulatory affairs department and all activities associated with the preparation of regulatory submissions.

    Qualifications

    • Bachelor’s degree preferably in a scientific, technical discipline or project management, Professional certification(s) preferred
    • 10+ years Regulatory Affairs, Medical Device experience required including international experience
    • 3+ years of management experience required
    • Ability to travel up to 25%
    • Demonstrated success in management of regulatory submissions activities including FDA and Notified Body experience
    • Experience supporting manufacturing/operations driven projects and achieving change approvals globally per business expectations
    • Strong understanding of product development process and ability to effectively partner cross-functionally
    • Strong technical knowledge of medical products & terminology
    • Excellent research and analytical skills
    • Ability to manage multiple projects simultaneously
    • Excellent written and oral communication, technical writing and editing skills

    Responsibilities

    • People manager for experienced Regulatory Affairs department, consisting of 6 direct reports.  These employees are based in Massachusetts, Denmark, and China. 
    • Provides technical guidance to team during submission preparation
    • Reviews and edits submissions prepared by team members
    • Implements regulatory strategies for new and modified products
    • Assists with developing and implementing departmental policy and procedure
    • Oversees preparation and submission of global regulatory applications as appropriate as well as internal regulatory file documentation
    • Oversees review of device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes
    • Reviews and signs-off product and manufacturing changes for compliance with applicable regulations

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