BS degree in a scientific discipline, preferably in the Life Sciences, Biomedical, Mechanical engineering or the equivalent in education, training and experience.
Minimum of 5-8 years of Regulatory experience in medical device industry is required. Minimum of 4 years of experience in working with regulatory agencies (i.e., FDA) and competent authorities.
· Regulatory Affairs Certification (RAC) a plus
· Knowledge of U.S. and International regulatory requirements for medical devices
· Proven record of supporting project teams
· Good Microsoft application skills
· Excellent written and oral communication skills
· Knowledge of current ISO 9001, ISO 13485, CMDR SOR/98-282, MDD 93/42/EEC, J-GMP and 21 CFR Part 820
Ability to work together with others and in a team atmosphere; while displaying civility, cordiality, friendliness, empathy, etc.
Ability to work in a fast-paced environment with varying amounts of individual responsibilities, conflict resolution, redirected priorities, etc.
Ability to travel nationally /internationally, up to 10-15% of the time