Associate Director Regulatory Affairs
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.