Associate Director Regulatory Affairs

North America, USA, Indiana, Kosciusko, Warsaw
$120000 - $160000 per annum + competitive
Dec 31, 2017
Jan 31, 2018
Brandon Johnson
Contract Type
Full Time
The Associate Director of Regulatory Affairs will be responsible for preparing Regulatory dossiers for domestic and international submissions. This position will manage a team in order to meet regulatory agency's needs and meet the company's deadlines. Below are the requirements and responsibilities: Education: * U.S. Bachelor's Degree * Regulatory Affairs Certification (U.S. or EU) preferred. Requirements: * 5-7 years prior RA experience. * Regulatory background should include the medical device area, and preferably should include orthopaedic experience. * Understands the overall business environment, the orthopaedic industry and the marketplace Responsibilities: * Oversees the development of dossiers for registration of products * Interprets and applies FDA regulations to business practices and provides regulatory input * Provide leadership and SME in all regulatory compliance audits * Manages post market surveillance activities * Ability to oversee day-to-day performance of employees, organize the function of a group, and provide leadership as necessary * Ability to function well as a member of the team and build relationships between RA and other areas of the organization Apply directly to Brandon Johnson at Real Staffing 312-453-9077 Sthree US is acting as an Employment Agency in relation to this vacancy.