President and founder of Novanel Engineering, providing solutions in regulatory affairs to wearable health technology companies. My experience leading regulatory affairs and product development allows me to succeed where others cannot – I bring solutions that allow regulatory compliance along with faster product development. I support all levels of organizations, providing executive level insight as well as hands-on solutions. I provide guidance on design controls, regulatory affairs strategy, software compliance, risk management, human factors engineering, verification and validation, technical file preparation, prepare submissions for marketing authorization and will help you respond to that 483 sitting on your desk. I have deep expertise in hearing aids and FDA OTC over-the-counter regulation. I am passionate about exploring new ideas, finding elegant solutions, and mentoring and developing the next generation of leaders within the medical device industry.
Listed skills include Manufacturing, Product Development, Testing, Design Of Experiments, and 23 others.