Regulatory Affairs Director

Job type:
permanent
Start:
09/2013
Duration:
n.a
From:
Real Staffing
Place:
Salt Lake City
Date:
08/09/2013
Country:
flag_no USA

Project description:
Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
Position Responsibilities:
  • Drive global regulatory strategy
  • Represent Regulatory team in inter-departmental matters
  • Ensure that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives
  • Communicate with domestic and international regulatory agencies
  • Establish project priorities to meet business objectives
  • Advise team of prevailing and evolving global regulatory requirements and environment
  • Develop, implement, and maintain policies and procedures
  • Foster employee career development


Required Skills
  • Extensive background in and knowledge of the development of regulatory submissions and documentation
  • Strong strategic, decision?making, and risk assessment abilities
  • Highly developed written and oral communication skills
  • Excellent organizational, leadership, and interpersonal skills


Required Experience
  • 510(k) or PMA submission experience
  • 7+ years Regulatory Affairs medical device industry experience
  • Bachelors degree required; advanced degree preferred


To find out more about Real please visit www.realstaffing.com