Project Manager, Regulatory

Integra LifeSciences   •  

Mansfield, MA

Industry: Healthcare

  •  

8 - 10 years

Posted 31 days ago

Responsibilities

This position is under minimal supervision of the Associate Director Regulatory Affairs

  • Manage activities and projects concerned with the submission and approval of products to government regulatory agencies to ensure compliance with regulations.
  • Develop world-wide regulatory strategies (with minimal supervision) to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
  • Provides guidance to project team members regarding regulatory and compliance issues by providing regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.
  • Prepares and maintains regulatory submissions and files including but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of neurosurgical products, including Class III devices.
  • Prepares necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
  • Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters.
  • Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
  • Represent Regulatory Affairs on cross-functional project teams


Qualifications

  • Bachelor degree with 7-9 years of experience or PhD, PharmD, MS with equivalent experience
  • Excellent written, verbal communication and presentation skills.
  • Experience in the preparation and submission of US and EU regulatory filings, including Class III devices.
  • Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.
  • Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
  • Consults with others to understand the benefits and risks associated with decision alternatives before making decisions.
  • Ability to work as a member of a team in a timeline-driven environment with limited supervision is required.
  • Practical experience in a medical device Regulatory environment, preparing submissions for Class II and Class III medical devices (US and EU).