Director of Regulatory Affairs and Quality Assurance

We have an immediate need for a Director of Regulatory Affairs and Quality Assurance in our Palm Beach Garden, FL location.  Identifies, plans, directs, oversees and assesses, throughout all facets of the business, policies, procedures, practices, etc. that together, establish systems compliant with laws, regulations and expectations of US Federal, State, Local and International regulatory agencies having jurisdiction over medical device manufacturing and distribution. Plans, develops, submits and coordinates regulatory agency registration/licensing and review/approval of new and revised product approval and distribution submissions. Develops, implements, and coordinates product assurance program to prevent or eliminate defects in new or existing products. Supervises multiple personnel of varying levels of responsibility including those of equal job experience and time, including indirect supervision of inspection staff on alternate shifts. Must currently have or be able to effectively develop a reasonable level of trust and respect of direct inspection staff and others at varying professional levels. Responsible for personnel management functions including interviewing, training, planning, assigning, and directing work. Responsible for development and management of the department's budget.  Skills Required: Bachelor's of science degree (B.S.) from a four-year college or university plus 7+ years related experience and/or training, or a combination of education and experience. American Society for Quality Certification for Quality Auditing or Quality Engineering. Ability to read, analyze and interpret common scientific and technical journals, reports, and quality/regulatory documents and product specifications. Must be able (or capable of learning) to operate effectively a variety of word processing (PC) programs including Microsoft Word, Excel, Outlook, Informix, and others. Must possess ability to respond to common inquiries or complaints from medical, technical and professional authorities, co-workers and members of supporting functions. Must have the ability to determine and assemble information for a variety of quality system performance reports and ability to present that information to higher professional authorities. Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Must possess ability to compute rate, ratio, and percent and to draw and interpret graphs. To be considered for this opening, please send a word formatted version of your resume and your salary requirements to mattbrown@oaot.com