Director, Regulatory Affairs - Class II Medical Device

Salt Lake City  ‐ Onsite
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Keywords

Description

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
  • Outgoing personality


Required Experience
  • Hands on 510(k) or PMA submission experience
  • 7+ years medical device industry experience
  • 5 years of regulatory management experience


To find out more about Real please visit www.realstaffing.com
Start date
10/2013
From
Real Staffing
Published at
16.10.2013
Project ID:
613509
Contract type
Permanent
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