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Associate Director of Regulatory Affairs

  • Job type: Permanent
  • Location: Boston, Massachusetts
  • Salary: US$145000 - US$195000 per year
  • Job reference: 338441/002_1562072824
  • Sector: Pharmacology, EPM Scientific
  • Date posted: 02/07/2019

My client is looking for an Associate Director of Regulatory Affairs. This person will be responsible for overseeing the regulatory affairs department and all activities associated with the preparation of regulatory submissions. The ideal candidate with also have experience managing a team as they have 6 direct reports based on site and internationally.

Based in the greater Boston area, this company is a leading provider of ultrasound-based, intraoperative guidance for surgical procedures within the U.S. and international healthcare markets.

Responsibilities

  • 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

Qualifications

  • Bachelor's degree preferably in a scientific, technical discipline or project management, Professional certification(s) preferred
  • 7+ 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

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