Regulatory Affairs Representative

Join us at the forefront of scientific discovery! At Bio-Rad Laboratories, you will participate in exciting new developments at the cutting-edge of science and technology. Our teams of dedicated professionals work together in an entrepreneurial atmosphere, providing a broad range of innovative tools and services to the clinical diagnostics and life science research markets. Bio-Rad was founded more than 40 years ago, and we are recognized as a world leader in science and research. Visit us at www.bio-rad.com Compile materials required for regulatory submissions; domestic and international. Ensure adequate documentation exists for all submitted data. Defend submissions before the FDA. Prepare new product technical files for CE Mark registration to the IVDD. Participate in the design review process. Participate in CAPA work, document control and labeling.Familiarity with IVD market and technologies used in BioPlex platforms a plus. Effective analytical and communication skills required. Must be solutions oriented. Must be able to handle multiple projects simultaneously. Requires a Bachelors degree in Biology, Chemistry, Medical Technology or related field.Advanced degree and/or Regulatory Affairs certification is a plus.2 years related experience in domestic and international compliance in the medical device industry. General background in FDA and CE Mark requirements.