Regulatory Affairs Manager, Diagnostics PMA 510(K)

FDA Regulatory Affairs Manager, PMA 510(k) Filing - Orange County, CAThis is an outstanding Regulatory Affairs position with an established Orange County Biotechnology company where you will be able to quickly advance your career and take on a managerial role.You will be responsible for providing assistance in supporting the process of meeting requirements established by U.S. and international governmental agencies in introducing immunoassay and molecular in vitro diagnostic products to market.  You will also plan and prepare PMA and 510K FDA submissions.  You will be a primary contact during FDA visits and FDA interactions.Preferred Candidate Background and Expertise: *  Bachelors Degree with a minimum of 5 years of Biotechnology, In Vitro Diagnostics, Medical Device or Pharmaceutical regulatory affairs experience.  *  Experience preparing PMA and 510K FDA submissions resulting in a successful in vitro diagnostic product approval. *  Strong knowledge of PMA, 510K, NDA, IND and DDMAC, ISO, GMP, GCP, ICH and GLP compliance standards. *  Experience in R&D, manufacturing, design control, quality systems and laboratory regulations.  *  Experience interacting directly with the FDA desired.We are offering a competitive salary with comprehensive benefits package and a team-oriented work environment.  For immediate confidential consideration please send your resume directly to Jeff Schwartzman: Jeff@LagunaSource.com Company: Laguna Source Location: Long Beach, CA Salary/Wage: 70,000.00 - 110,000.00 /year Status: Full Time, Employee Job Category: Biotech/R&D/Science Relevant Work Experience: 2+ to 5 Years Career Level: Experienced (Non-Manager) Education Level: Bachelor's Degree