RA Specialist I, Business Requirements RIM - 1MDTR
Location:
New Brunswick , New Jersey
Posted:
January 12, 2017
Reference:
4374161219-en-us

Johnson & Johnson is hiring for a Regulatory Affairs Specialist, Business Requirements RIM, located at any medical device site within the US or remote based.  The RA Specialist Business Requirements RIM is responsible for gathering critical business requirements and translating into design specifications for the development of an integrated cross-MD Regulatory information technology solution that will facilitate global tracking, business workflow, reporting and analysis of critical Regulatory information and work output, including product registration, health authority interaction, document/content management, communications, and business analytics. RIM will serve as the lifeblood to the regulatory life-cycle management of all products  across multiple Medical Devices business units globally.

 

POSITION DUTIES & RESPONSIBILITIES:

  • Develop business requirements gathering strategy with Knowledge Management Lead and RIM Project Manager
  • Rapidly gain an understanding of RIM vision for J&J Medical Devices
  • Coordinate with RIM PM and RIM Data Analysis Team to develop an accelerated plan for data gathering and analysis phase
  • Execute data gathering plan
  • Provide RIM business design framework to support future business needs
  • Ensure project remains on schedule, on budget and meets the needs of the business
  • Identify critical gaps or deficiencies in project resources
  • Identify/manage critical issues; provide timely escalation to management
  • Prepare and present project dashboards/progress checks at regular intervals
  • Coordinate/drive critical business involvement on key project activities
  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
  • Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
  • Performs other related duties as required.
  • Assignment length for the Regulatory Affairs Specialist, Business Requirements RIM, expected to last approximately 18 to 24 months


Qualifications

  • ·         A minimum of a Bachelor’s degree preferred
  • ·         Some college coursework is required
  • ·         2 years of Regulatory Operations / IT experience relevant experience required
  • ·         Previous business requirements gathering experience required
  • ·         Preferred experience working within health care regulatory environment such as medical devices, pharmaceuticals or consumer products is required
  • ·         An ability to travel a minimum of 10% is required


Primary Location
United States-New Jersey-New Brunswick
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Regulatory Affairs

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

Know someone who would be interested in this job? Share it with your network.